FDA.reportPublic FDA data

Clotrimazole Cream

Product NDC
87236-014
11-digit product format
872360014
Labeler code
87236
Product ID
87236-014_53bdd76b-6291-f1d3-e063-6394a90a9ff1
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole USP1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
Clotrimazole Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

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
53bdd76b-6290-f1d3-e063-6394a90a9ff1Available on FDA.report

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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
Micotrin ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
application number: M005
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsExact identifier
application number: M005
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
application number: M005
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
application number: M005
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
application number: M005
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
application number: M005
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M005
Mentholatum Heel Revival CreamMENTHOLATUM HEEL REVIVAL CREAMThe Mentholatum Company21b643c2-eb6e-8939-e063-6394a90aaeac2024-09-09WarningsExact identifier
application number: M005
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Tropical Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.3645359c-06a2-4b97-b982-c54e4a0b8cda2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Coastal Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.645c09dc-15a4-481f-a605-f12fb8f8e9bd2024-09-04WarningsExact identifier
application number: M005
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
application number: M005
ANTIFUNGAL FOOTTOLNAFTATEUniversal Distribution Center LLC10579848-5793-4d72-ad5f-62d191c710742024-07-16WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-014-14872360014141 TUBE in 1 CARTON (87236-014-14) / 14.2 g in 1 TUBE1 tube2026-06-01NoNoCurrent
87236-014-28872360014281 TUBE in 1 CARTON (87236-014-28) / 28.4 g in 1 TUBE1 tube2026-06-01NoNoCurrent