FDA.reportPublic FDA data

HEB

Product NDC
37808-305
11-digit product format
378080305
Labeler code
37808
Product ID
37808-305_39adf5d6-2001-9513-e063-6294a90a14c5
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-08-31
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

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
HEB
Brand name suffix
Antifungal
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
8f07dc5a-cfa8-4a57-ac90-552a7c947cc5Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-305-01HEBAntifungal14.2 g in 1 TUBECREAM14.25
37808-305-01HEBAntifungal1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65HEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
ClotrimazoleACTIVE MOIETYG07GZ97H65HEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
octyldodecanolINACTIVE INGREDIENT461N1O614YHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2
waterINACTIVE INGREDIENT059QF0KO0RHEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-305HEB ANTIFUNGAL (CLOTRIMAZOLE) CREAM [H E B]4Current NDC, Legacy NDC, 2 package rows20241115_8f07dc5a-cfa8-4a57-ac90-552a7c947cc5.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 44 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN8f07dc5a-cfa8-4a57-ac90-552a7c947cc55
309367clotrimazole 10 MG/ML Topical CreamSCD8f07dc5a-cfa8-4a57-ac90-552a7c947cc55
309367clotrimazole 1 % Topical CreamSY8f07dc5a-cfa8-4a57-ac90-552a7c947cc55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-305-01378080305011 TUBE in 1 CARTON (37808-305-01) / 14.2 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent