FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
51672-2001
Requested package NDC
51672-2001-2
11-digit product format
516722001
Labeler code
51672
Product ID
51672-2001_59d8ccc0-136d-dfa7-e063-6394a90adde1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-10-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole Nitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fd4037e-d350-47b7-a7d9-a43b8e366fa0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2001-1Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-1Miconazole Nitrate15 g in 1 TUBECREAM155
51672-2001-2Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-2Miconazole Nitrate30 g in 1 TUBECREAM305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2001-1GM - Gram51672-20019dbd7e37-8219-4939-b49c-0359e914af9712012-07-24
51672-2001-2GM - Gram51672-20019cf50338-1157-450f-91bd-7c055b0d494812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
apricot kernel oilINACTIVE INGREDIENT54JB35T06AMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
glycol stearateINACTIVE INGREDIENT0324G66D0EMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B0MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2001MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241222_7fd4037e-d350-47b7-a7d9-a43b8e366fa0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Velloryn ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4e38e1f1-0466-5b91-e063-6294a90a66c42026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Daytime AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3d226b-57f1-75a6-e063-6394a90a96cd2026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Nighttime AntifungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3e8895-34b4-de69-e063-6294a90a55322026-03-30Exact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREECVS Pharmacy3380263d-ee7b-4946-a467-35a24789a9012026-03-27WarningsExact identifier
application number: M005
Micro-Guard (AF)MICONAZOLE NITRATEColoplast Corpa43a94d0-fec0-470f-bdb4-535dcce6d1e02026-03-27WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Fresh CitrusLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d77ec6-a1d1-13dc-e063-6394a90a95f42026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Deeply CleanLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d83736-66da-abb9-e063-6294a90a3d672026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe VeraLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d8848c-d157-6e2c-e063-6294a90aa2592026-03-26WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
application number: M005
Toenail Fungus TreatmentTERBINAFINEShenzhen Wankelai E-commerce Co., Ltd.4dc1d7f7-e4ae-c54b-e063-6394a90aa4202026-03-24WarningsExact identifier
application number: M005
Lasolex Liquid SolutionCLOTRIMAZOLE 1%PureTek Corporation4dc9e64d-8235-b218-e063-6394a90a01572026-03-24WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. BarTOLNAFTATE 1%Beautivity LLC4dbbf09b-5bc1-501b-e063-6394a90a2a9d2026-03-23WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
application number: M005
seebeellar clotrimazole 1% antifungal creamSEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd4d80e551-76c2-150a-e063-6394a90a79962026-03-20WarningsExact identifier
application number: M005
Nail Fungal PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5b5c22-4781-6391-e063-6294a90a70102026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
application number: M005
Toenail Fungus PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5e256f-7fd5-f903-e063-6394a90a11602026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN7fd4037e-d350-47b7-a7d9-a43b8e366fa05
998483miconazole nitrate 20 MG/ML Topical CreamSCD7fd4037e-d350-47b7-a7d9-a43b8e366fa05
998483miconazole nitrate 2 % Topical CreamSY7fd4037e-d350-47b7-a7d9-a43b8e366fa05
998483miconazole nitrate 2 % Topical CreamPSNbf131f33-3ab2-4f43-add5-920e78ac36a74
998483miconazole nitrate 20 MG/ML Topical CreamSCDbf131f33-3ab2-4f43-add5-920e78ac36a74
998483miconazole nitrate 2 % Topical CreamSYbf131f33-3ab2-4f43-add5-920e78ac36a74
998483miconazole nitrate 2 % Topical CreamPSN23ca78c0-16a9-455c-99a7-b9a9a3affa603
998483miconazole nitrate 20 MG/ML Topical CreamSCD23ca78c0-16a9-455c-99a7-b9a9a3affa603
998483miconazole nitrate 2 % Topical CreamSY23ca78c0-16a9-455c-99a7-b9a9a3affa603
998483miconazole nitrate 2 % Topical CreamPSNda4702fa-d3e9-7c71-e053-2995a90af3341
998483miconazole nitrate 20 MG/ML Topical CreamSCDda4702fa-d3e9-7c71-e053-2995a90af3341
998483miconazole nitrate 2 % Topical CreamSYda4702fa-d3e9-7c71-e053-2995a90af3341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2001-2516722001021 TUBE in 1 CARTON (51672-2001-2) / 30 g in 1 TUBE1 tube1991-10-010000-00-00NoNoCurrent