miconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
systemic antifungal agents, miconazole derivatives	1800	22916-47-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: miconazole miconazole nitrate	An imidazole antifungal agent that is used topically and by intravenous infusion. Molecular weight: 416.12 Formula: C18H14Cl4N2O CLOGP: 5.81 LIPINSKI: 1 HAC: 3 HDO: 0 TPSA: 27.05 ALOGS: -5.74 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

miconazole
miconazole nitrate

An imidazole antifungal agent that is used topically and by intravenous infusion.

Molecular weight: 416.12
Formula: C18H14Cl4N2O
CLOGP: 5.81
LIPINSKI: 1
HAC: 3
HDO: 0
TPSA: 27.05
ALOGS: -5.74
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.20	g	O
1	g	O
0.10	g	V
1	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	144.18 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	25 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	7.14 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	9.48 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.08 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	19.75 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 8, 1974	FDA	INSIGHT PHARMS
Dec. 30, 1985	PMDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
International normalised ratio increased	230.42	16.01	103	5710	46322	63436887
Drug interaction	183.63	16.01	158	5655	228973	63254236
Hydronephrosis	67.02	16.01	28	5785	10634	63472575
Cholestasis of pregnancy	58.57	16.01	15	5798	1210	63481999
Vulvovaginal burning sensation	46.18	16.01	14	5799	2095	63481114
Haemorrhage subcutaneous	45.38	16.01	15	5798	2968	63480241
Encephalitis fungal	44.34	16.01	7	5806	43	63483166
Haematuria	40.53	16.01	28	5785	29129	63454080
Cancer pain	40.42	16.01	14	5799	3191	63480018
Pericardial effusion	39.76	16.01	28	5785	30030	63453179
Sepsis neonatal	39.02	16.01	9	5804	467	63482742
Nail dystrophy	32.02	16.01	9	5804	1034	63482175
Neuropathy peripheral	29.94	16.01	44	5769	113623	63369586
Haematoma	29.72	16.01	25	5788	34795	63448414
Vulvovaginal pruritus	29.04	16.01	11	5802	3232	63479977
Drug ineffective	26.82	16.01	34	5779	1044731	62438478
Axillary pain	26.32	16.01	9	5804	1974	63481235
Lip swelling	25.88	16.01	22	5791	31041	63452168
Vulvovaginal candidiasis	25.68	16.01	10	5803	3165	63480044
Hypokalaemia	25.64	16.01	39	5774	103765	63379444
Vaginal erosion	24.88	16.01	4	5809	28	63483181
Vulvovaginal pain	23.49	16.01	9	5804	2726	63480483
Dry skin	22.68	16.01	27	5786	56860	63426349
Benign vulval neoplasm	22.24	16.01	4	5809	58	63483151
Premature labour	22.21	16.01	14	5799	12490	63470719
Catheter site haemorrhage	22.19	16.01	9	5804	3166	63480043
Drug withdrawal syndrome neonatal	22.10	16.01	8	5805	2073	63481136
Fungal sepsis	21.80	16.01	7	5806	1263	63481946
Fungal infection	20.79	16.01	21	5792	36853	63446356
Joint swelling	20.16	16.01	3	5810	327663	63155546
Jarisch-Herxheimer reaction	19.92	16.01	5	5808	372	63482837
Facial pain	19.20	16.01	12	5801	10549	63472660
Eosinophilia	18.72	16.01	16	5797	22740	63460469
Drug intolerance	18.59	16.01	3	5810	308658	63174551
Rash erythematous	18.31	16.01	21	5792	42489	63440720
Vulvovaginal swelling	18.03	16.01	5	5808	546	63482663
Pneumomediastinum	17.06	16.01	6	5807	1430	63481779
Appendicitis	16.62	16.01	10	5803	8219	63474990
Drug hypersensitivity	16.45	16.01	64	5749	310623	63172586
Retroperitoneal haematoma	16.14	16.01	7	5806	2906	63480303
Sepsis	16.01	16.01	40	5773	153083	63330126

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
International normalised ratio increased	169.69	18.87	84	3143	47243	34906461
Drug interaction	147.71	18.87	139	3088	225807	34727897
Coagulation time prolonged	29.98	18.87	9	3218	1293	34952411
Haematuria	28.97	18.87	29	3198	50037	34903667
Oedema genital	27.93	18.87	7	3220	513	34953191
Ocular myasthenia	27.74	18.87	6	3221	230	34953474
Genital rash	22.39	18.87	6	3221	572	34953132
Pharyngeal haematoma	21.72	18.87	4	3223	66	34953638
Haemorrhage subcutaneous	21.17	18.87	8	3219	2316	34951388

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
International normalised ratio increased	307.10	15.99	154	7572	84567	79652095
Drug interaction	242.47	15.99	246	7480	414937	79321725
Cholestasis of pregnancy	50.89	15.99	13	7713	980	79735682
Hydronephrosis	49.54	15.99	27	7699	17427	79719235
Haematuria	47.68	15.99	45	7681	68791	79667871
Cancer pain	39.72	15.99	16	7710	5229	79731433
Sepsis neonatal	35.85	15.99	6	7720	52	79736610
Nail dystrophy	31.77	15.99	9	7717	1004	79735658
Pericardial effusion	29.68	15.99	29	7697	46208	79690454
Hypokalaemia	27.85	15.99	50	7676	143990	79592672
Vulvovaginal candidiasis	27.40	15.99	10	7716	2504	79734158
Haematoma	26.74	15.99	29	7697	52166	79684496
Oedema genital	26.53	15.99	7	7719	599	79736063
Seizure	26.17	15.99	57	7669	188777	79547885
Drug withdrawal syndrome neonatal	25.95	15.99	6	7720	297	79736365
Dry skin	25.21	15.99	32	7694	67963	79668699
Axillary pain	25.11	15.99	9	7717	2140	79734522
Ocular myasthenia	24.49	15.99	6	7720	381	79736281
Premature labour	23.86	15.99	13	7713	8377	79728285
Coagulation time prolonged	23.80	15.99	9	7717	2486	79734176
Catheter site haemorrhage	23.60	15.99	11	7715	5106	79731556
Lip swelling	23.21	15.99	24	7702	40887	79695775
Benign vulval neoplasm	22.01	15.99	4	7722	58	79736604
Haemorrhage subcutaneous	21.14	15.99	10	7716	4799	79731863
Neuropathy peripheral	21.12	15.99	44	7682	141261	79595401
Urinary tract infection	20.68	15.99	66	7660	274446	79462216
Premature baby	20.19	15.99	9	7717	3771	79732891
Labelled drug-drug interaction medication error	18.98	15.99	18	7708	27632	79709030
Dementia	18.76	15.99	17	7709	24642	79712020
Pharyngeal haematoma	18.59	15.99	4	7722	142	79736520
Sepsis	17.82	15.99	62	7664	269366	79467296
Onychomadesis	17.39	15.99	9	7717	5233	79731429
Pneumomediastinum	17.27	15.99	8	7718	3659	79733003
Therapeutic agent-diagnostic test interaction	17.19	15.99	3	7723	34	79736628
Contusion	16.32	15.99	41	7685	148735	79587927
Eosinophilia	16.27	15.99	21	7705	45324	79691338
Vulvovaginal burning sensation	16.03	15.99	6	7720	1611	79735051

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A01AB09	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Antiinfectives and antiseptics for local oral treatment
ATC	A07AC01	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Imidazole derivatives
ATC	D01AC02	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Imidazole and triazole derivatives
ATC	D01AC52	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Imidazole and triazole derivatives
ATC	G01AF04	GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Imidazole derivatives
ATC	J02AB01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Imidazole derivatives
ATC	S02AA13	SENSORY ORGANS OTOLOGICALS ANTIINFECTIVES Antiinfectives
FDA CS	M0002083	Azoles
FDA EPC	N0000175487	Azole Antifungal
MeSH PA	D058888	14-alpha Demethylase Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents
MeSH PA	D065688	Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA	D065692	Cytochrome P-450 CYP3A Inhibitors
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D065088	Steroid Synthesis Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:75282	ergosterol biosynthesis inhibitors
CHEBI has role	CHEBI:82891	glucocorticoid receptor antagonists

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Tinea pedis	indication	6020002	DOID:12403
Candidiasis of skin	indication	49883006
Pityriasis versicolor	indication	56454009	DOID:9060
Candidal vulvovaginitis	indication	72605008	DOID:2272
Candidiasis of mouth	indication	79740000	DOID:14262
Tinea corporis	indication	84849002
Diaper rash	indication	91487003
Tinea cruris	indication	399029005
Onychomycosis due to dermatophyte	indication	402134005
Deep mycosis	indication	716203000
Oropharyngeal Candidiasis	indication
Paronychia	off-label use	71906005	DOID:13117
Disease of liver	contraindication	235856003	DOID:409

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Infections caused by Microsporum canis	Indication
Cats	Infections caused by Microsporum gypseum	Indication
Cats	Infections caused by Trichophyton mentagrophytes	Indication
Dogs	Infections caused by Microsporum canis	Indication
Dogs	Infections caused by Microsporum gypseum	Indication
Dogs	Infections caused by Trichophyton mentagrophytes	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Conofite Cream 2%	Intervet Inc.	1
Conofite Lotion 1%	Intervet Inc.	1
Surolan	Elanco US Inc.	3
Easotic	Virbac AH Inc.	3
Miconosol	Med-Pharmex Inc.	1
Priconazole Lotion 1% and Spray 1%	First Priority Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.49	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.25%;81.35%;15%	VUSION	MYLAN	N021026	Feb. 16, 2006	RX	OINTMENT	TOPICAL	8147852	March 30, 2028	USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	5.14	DRUG MATRIX
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN		IC50	4.59	DRUG MATRIX
Cannabinoid receptor 1	GPCR	P21554	CNR1_HUMAN		Ki	4.78	DRUG MATRIX
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN		Ki	5.61	DRUG MATRIX
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Ki	5.51	DRUG MATRIX
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	5.38	DRUG MATRIX
Adenosine receptor A2a	GPCR	P29274	AA2AR_HUMAN		Ki	5.10	DRUG MATRIX
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	5.83	DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN				WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		IC50	7	DRUG MATRIX
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	6.38	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.54	DRUG MATRIX
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.18	DRUG MATRIX
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	5.95	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.45	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	5.56	DRUG MATRIX
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	5.30	DRUG MATRIX
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.79	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.96	DRUG MATRIX
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.18	DRUG MATRIX
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	6.02	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	5.81	DRUG MATRIX
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	6.18	DRUG MATRIX
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	6.35	DRUG MATRIX
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		Ki	5.39	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.87	DRUG MATRIX
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		IC50	6	DRUG MATRIX
Adenosine receptor A1	GPCR	P30542	AA1R_HUMAN		Ki	5.14	DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.80	DRUG MATRIX
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN		Ki	5.27	DRUG MATRIX
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	5.83	DRUG MATRIX
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		Ki	5.58	DRUG MATRIX
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	5.92	DRUG MATRIX
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		IC50	4.73	DRUG MATRIX
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	6.70	DRUG MATRIX
Aromatase	Enzyme	P11511	CP19A_HUMAN		IC50	6.22	CHEMBL
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		IC50	4.53	DRUG MATRIX
Substance-P receptor	GPCR	P25103	NK1R_HUMAN		Ki	5.43	DRUG MATRIX
Steroid 17-alpha-hydroxylase/17,20 lyase	Enzyme	P05093	CP17A_HUMAN		Ki	6.61	CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	7.80	DRUG MATRIX
Alkaline phosphatase, tissue-nonspecific isozyme	Enzyme	P05186	PPBT_HUMAN		EC50	4.15	CHEMBL
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.38	DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		IC50	4.56	DRUG MATRIX
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN		IC50	6.58	DRUG MATRIX
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		IC50	6.70	CHEMBL
Indoleamine 2,3-dioxygenase 1	Enzyme	P14902	I23O1_HUMAN		IC50	5.42	CHEMBL
Type-2 angiotensin II receptor	GPCR	P50052	AGTR2_HUMAN		Ki	5.11	DRUG MATRIX
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	5.79	DRUG MATRIX
Melanocortin receptor 4	GPCR	P32245	MC4R_HUMAN		Ki	4.92	DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN		Ki	4.67	DRUG MATRIX
Melanocortin receptor 3	GPCR	P41968	MC3R_HUMAN		Ki	4.79	DRUG MATRIX
Malate dehydrogenase cytoplasmic	Enzyme	P40925	MDHC_HUMAN		IC50	4.60	CHEMBL
Calcium release-activated calcium channel protein 1	Ion channel	Q96D31	CRCM1_HUMAN		IC50	4.57	CHEMBL
7-alpha-hydroxycholest-4-en-3-one 12-alpha-hydroxylase	Enzyme	Q9UNU6	CP8B1_HUMAN		IC50	5.82	CHEMBL
Lanosterol 14-alpha demethylase	Enzyme		CP51_CANAL	INHIBITOR			CHEMBL	CHEMBL
Beta-lactamase	Enzyme		AMPC_ECOLI		IC50	4.40	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	5.33	DRUG MATRIX
5-hydroxytryptamine receptor 1B	GPCR		5HT1B_RAT		Ki	5.03	DRUG MATRIX
Membrane-associated progesterone receptor component 1	Membrane receptor		PGRC1_RAT		Ki	5.69	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	5.71	DRUG MATRIX
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	4.94	CHEMBL
Acetylcholinesterase	Enzyme		ACES_ELEEL		IC50	4.67	CHEMBL
Aromatase	Enzyme		CP19A_RAT		EC50	6.40	CHEMBL
Cholinesterase	Enzyme		CHLE_HORSE		IC50	5.17	CHEMBL
Lanosterol 14-alpha demethylase	Enzyme		CP51_MYCTU		Kd	6.70	CHEMBL
Indoleamine 2,3-dioxygenase 2	Enzyme		I23O2_MOUSE		IC50	5.17	CHEMBL
Mycocyclosin synthase	Enzyme		CP121_MYCTU		Kd	7.14	CHEMBL
Indoleamine 2,3-dioxygenase 1	Enzyme		I23O1_MOUSE		IC50	4.75	CHEMBL
Fatty acid hydroperoxide lyase, chloroplastic	Enzyme		HPL_SOLLC		IC50	4.19	CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2	Ion channel		AT1A2_PIG		IC50	4.72	DRUG MATRIX

External reference:

ID	Source
4018555	VUID
N0000146875	NUI
D00416	KEGG_DRUG
22832-87-7	SECONDARY_CAS_RN
4018554	VANDF
4018555	VANDF
C0025942	UMLSCUI
CHEBI:6923	CHEBI
CHEMBL91	ChEMBL_ID
CHEMBL1559	ChEMBL_ID
D008825	MESH_DESCRIPTOR_UI
DB01110	DRUGBANK_ID
4189	PUBCHEM_CID
2449	IUPHAR_LIGAND_ID
2728	INN_ID
7NNO0D7S5M	UNII
42790	RXNORM
1135	MMSL
36502	MMSL
5112	MMSL
5113	MMSL
7143	MMSL
d00155	MMSL
002918	NDDF
002919	NDDF
372738006	SNOMEDCT_US
42720001	SNOMEDCT_US
60727003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Good Sense Miconazole 7	HUMAN OTC DRUG LABEL	1	0113-0214	CREAM	2 g	VAGINAL	ANDA	17 sections
good sense miconazole 7	HUMAN OTC DRUG LABEL	1	0113-0825	CREAM	2 g	VAGINAL	ANDA	17 sections
basic care miconazole 3	HUMAN OTC DRUG LABEL	1	0113-7070	CREAM	40 mg	VAGINAL	ANDA	17 sections
basic care miconazole 7	HUMAN OTC DRUG LABEL	1	0113-7825	CREAM	2 g	VAGINAL	ANDA	17 sections
Selan Antifungal	HUMAN OTC DRUG LABEL	1	0159-2500	CREAM	2 g	TOPICAL	OTC monograph final	12 sections
Selan Antifungal	HUMAN OTC DRUG LABEL	1	0159-2500	CREAM	2 g	TOPICAL	OTC monograph final	12 sections
Desenex	HUMAN OTC DRUG LABEL	1	0316-0225	POWDER	20 mg	TOPICAL	OTC monograph final	13 sections
Zeasorb	HUMAN OTC DRUG LABEL	1	0316-0231	POWDER	20 mg	TOPICAL	OTC monograph final	12 sections
Zeasorb	HUMAN OTC DRUG LABEL	1	0316-0232	POWDER	20 mg	TOPICAL	OTC monograph final	12 sections
Athletes Foot	HUMAN OTC DRUG LABEL	1	0363-0557	SPRAY	2 g	TOPICAL	OTC monograph final	13 sections
Miconazole 7	HUMAN OTC DRUG LABEL	1	0363-0730	CREAM	20 mg	VAGINAL	ANDA	17 sections
Miconazole 7	HUMAN OTC DRUG LABEL	1	0363-0730	CREAM	20 mg	VAGINAL	ANDA	17 sections
Jock Itch	HUMAN OTC DRUG LABEL	1	0363-1497	SPRAY	2 g	TOPICAL	OTC monograph final	13 sections
miconazole 3	HUMAN OTC DRUG LABEL	1	0363-2070	CREAM	40 mg	VAGINAL	ANDA	17 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-3115	POWDER	1.42 g	TOPICAL	OTC monograph final	13 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-3115	POWDER	1.42 g	TOPICAL	OTC monograph final	13 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-4208	SPRAY	3 g	TOPICAL	OTC monograph final	13 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-4208	SPRAY	3 g	TOPICAL	OTC monograph final	13 sections
Miconazole Nitrate 2%	HUMAN OTC DRUG LABEL	1	0363-5353	AEROSOL, SPRAY	1.30 g	TOPICAL	OTC monograph final	14 sections
Miconazole Nitrate 2%	HUMAN OTC DRUG LABEL	1	0363-5353	AEROSOL, SPRAY	1.30 g	TOPICAL	OTC monograph final	14 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-7418	AEROSOL, SPRAY	2.60 g	TOPICAL	OTC monograph final	13 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0363-7418	AEROSOL, SPRAY	2.60 g	TOPICAL	OTC monograph final	13 sections
VUSION	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8222	OINTMENT	2.50 mg	TOPICAL	NDA authorized generic	26 sections
VUSION	HUMAN PRESCRIPTION DRUG LABEL	3	0378-9730	OINTMENT	2.50 mg	TOPICAL	NDA	26 sections
Miconazole 7	HUMAN OTC DRUG LABEL	1	0472-0730	CREAM	20 mg	VAGINAL	ANDA	17 sections
Antifungal	HUMAN OTC DRUG LABEL	1	0472-0735	CREAM	20 mg	TOPICAL	OTC monograph final	13 sections
Antifungal	HUMAN OTC DRUG LABEL	1	0472-0735	CREAM	20 mg	TOPICAL	OTC monograph final	13 sections
Miconazole 7	HUMAN OTC DRUG LABEL	1	0472-1736	SUPPOSITORY	100 mg	VAGINAL	ANDA	17 sections
Miconazole Nitrate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-1738	SUPPOSITORY	200 mg	VAGINAL	ANDA	16 sections
Miconazole Nitrate	HUMAN OTC DRUG LABEL	1	0536-1134	CREAM	20 mg	TOPICAL	OTC MONOGRAPH FINAL	14 sections