FDA.reportPublic FDA data

Clotrimazole

Product NDC
80489-002
11-digit product format
804890002
Labeler code
80489
Product ID
80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7
Type
HUMAN OTC DRUG
Nonproprietary name
Drs. Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
OL PHARMA TECH,LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage80489-002-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80489-002-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80489-002-01bd6a592717d7…303034d00443…

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
Clotrimazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0e9fc77-6d5c-2472-e053-2995a90a3de4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80489-002-012023-01-17C16284748780-1d6a99b39-4d82-a426-e053-dadaa90af4c2b0e9fc77-6d5c-2472-e053-2995a90a3de4
80489-002-012022-01-28C16284748780-1d6a99b39-4d82-a426-e053-dadaa90af4c2b0e9fc77-6d5c-2472-e053-2995a90a3de4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-002-01Clotrimazole1 in 1 CARTONCREAM14
80489-002-01Clotrimazole28.3 g in 1 TUBECREAM28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-002CLOTRIMAZOLE (DRS. CLOTRIMAZOLE) CREAM [OL PHARMA TECH,LLC]4Current NDC, Legacy NDC, 2 package rows20250112_b0e9fc77-6d5c-2472-e053-2995a90a3de4.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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
application number: M005
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
application number: M005
Molecular AFTOLNAFTATERenu Laboratories, LLC1b47e687-29cf-48ce-8bc3-ac8f44f05baa2025-02-03WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
application number: M005
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
application number: M005
AWAS ALCOHOLSPRAYALCOHOLIDO PHARM03010837-0289-3e08-e063-6394a90a7d042025-01-30WarningsExact identifier
application number: M005
ELON Dual Defense Anti Fungal FormulaUNDECYLENIC ACIDLittle Giant Holdings LLC45c4567d-7876-6459-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M005
DCH Labs Antifungal JockMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCfc749882-2e1e-cad3-e053-6294a90a33ca2025-01-27WarningsExact identifier
application number: M005
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
application number: M005
Mata HongosUNDECYLENIC ACIDVitamex USA, Corp21ca7edb-dde3-5846-e063-6394a90a3cc02025-01-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGALTOLNAFTATENatureplex, LLC575b8645-9166-4242-a74f-f4aa4acaaf3d2025-01-15WarningsExact identifier
application number: M005
Tobcharm Antifungal Treatment CreamANTIFUNGAL TREATMENT CREAMGuangzhou Zanming Trading Co., Ltd.2ba241cc-2767-1190-e063-6294a90ac66b2025-01-13WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
application number: M005
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNb0e9fc77-6d5c-2472-e053-2995a90a3de44
309367clotrimazole 10 MG/ML Topical CreamSCDb0e9fc77-6d5c-2472-e053-2995a90a3de44
309367clotrimazole 1 % Topical CreamSYb0e9fc77-6d5c-2472-e053-2995a90a3de44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-002-01804890002011 TUBE in 1 CARTON (80489-002-01) / 28.3 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent