FDA.reportPublic FDA data

Micatin

Product NDC
65197-103
11-digit product format
651970103
Labeler code
65197
Product ID
65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-24
Marketing end
2026-11-30
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
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
Micatin

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup
998509Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
96c56ba1-c3a8-48ce-ab58-550959485e3cAvailable 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
65197-103-05Micatin14 g in 1 TUBECREAM1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-103-05GM - Gram65197-103efc568b5-c1ec-4767-b2b3-a2c85664732d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]5
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-103MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]11Current NDC, Legacy NDC, 1 package rows20240711_96c56ba1-c3a8-48ce-ab58-550959485e3c.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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
application number: M005
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
application number: M005
AVON HeXashield Athletes Foot CreamTOLNAFTATETai Guk Pharm. Co., Ltd.8f2b6a09-8cb0-0d17-e053-2995a90aa07f2025-01-01WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE 1%Trifecta Pharmaceuticals USA, LLC091b907f-544a-86c9-e063-6294a90a5d872024-12-31WarningsExact identifier
application number: M005
terrasil Fungal TreatmentCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions278290f9-be14-81a8-e063-6294a90ad8cc2024-12-26WarningsExact identifier
application number: M005
DEO PEDICO ABOVE NEYMAR JR MENDEO PEDICO ABOVE NEYMAR JR MENBASTON INDUSTRIA DE AEROSSOIS LTDAed4a9844-f20b-da5d-e053-2995a90adc092024-12-26WarningsExact identifier
application number: M005
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
application number: M005
Vite20UNDECYLENIC ACIDBlaine Labs Inc.18f8ea1c-360e-43c0-98df-5816af4dec662024-12-24WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALFAMILY WELLNESS TOLNAFTATETrifecta Pharmaceuticals USA, LLC915759af-0d7f-6a87-e053-2a95a90acbd62024-12-20WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYPremier Brands of America Inc.dc7a23bb-b246-89b1-e053-2995a90a9f2d2024-12-20WarningsExact identifier
application number: M005
Warrior Antifungal FootMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCcf2e9dc1-275b-4454-e053-2995a90af2952024-12-20WarningsExact identifier
application number: M005
Tolnaftate Cream 1%TOLNAFTATEPharmacy Value Alliance, LLC.3abfd734-229b-1a0e-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Derma Care Research Labs, LLCfbc1a55e-b994-4962-e053-6394a90a13ba2024-12-19WarningsExact identifier
application number: M005
Novonail SolutionTOLNAFTATE 1%Derma Care Research Labs, LLC013d6107-e3b0-0264-e063-6394a90ae1e22024-12-19WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
application number: M005
Relispray Antifungal LiquidTOLNAFTATEMidas-Care Pharmaceuticals Pvt. Ltd.6522ad59-f810-408c-a9f9-9359d79302ce2024-12-17WarningsExact identifier
application number: M005
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
application number: M005
Blistex Odor-Eaters PowderTOLNAFTATEBlistex Inc819edb2f-dda7-45c3-b0da-ebcae354154e2024-12-12WarningsExact identifier
application number: M005
Walgreens Athletes FootTOLNAFTATE SPRAYWalgreensc68ad65d-b016-0069-e053-2995a90ae7ef2024-12-11WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998509Micatin 2 % Topical CreamPSN96c56ba1-c3a8-48ce-ab58-550959485e3c11
998483miconazole nitrate 2 % Topical CreamPSN96c56ba1-c3a8-48ce-ab58-550959485e3c11
998509miconazole nitrate 20 MG/ML Topical Cream [Micatin]SBD96c56ba1-c3a8-48ce-ab58-550959485e3c11
998483miconazole nitrate 20 MG/ML Topical CreamSCD96c56ba1-c3a8-48ce-ab58-550959485e3c11
998509Micatin 2 % Topical CreamSY96c56ba1-c3a8-48ce-ab58-550959485e3c11
998509Micatin 20 MG/ML Topical CreamSY96c56ba1-c3a8-48ce-ab58-550959485e3c11
998483miconazole nitrate 2 % Topical CreamSY96c56ba1-c3a8-48ce-ab58-550959485e3c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-103-056519701030514 g in 1 TUBE (65197-103-05) 14 g2009-06-242026-11-30NoNoCurrent