FDA.reportPublic FDA data

CLOTRIMAZOLE

Product NDC
54162-018
11-digit product format
541620018
Labeler code
54162
Product ID
54162-018_ce329877-f502-4829-8609-553bc3259aa1
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Geritrex Corp
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-29
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-018-052019-11-27C16284748780-19855e2a2-3e61-60a7-e053-dbdaa90a05bdClotrimazole Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-018-05CLOTRIMAZOLE14 g in 1 TUBECREAM141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-018-05GM - Gram54162-01885c0e3f6-bd22-4782-b4dc-6d9117dc99e212014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [GERITREX CORP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [GERITREX CORP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [GERITREX CORP]1
CETEARETH-2 PHOSPHATEINACTIVE INGREDIENT8NSU66JGZRCLOTRIMAZOLE CREAM [GERITREX CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOTRIMAZOLE CREAM [GERITREX CORP]1
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUCLOTRIMAZOLE CREAM [GERITREX CORP]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZECLOTRIMAZOLE CREAM [GERITREX CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE CREAM [GERITREX CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLOTRIMAZOLE CREAM [GERITREX CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOTRIMAZOLE CREAM [GERITREX CORP]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOTRIMAZOLE CREAM [GERITREX CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE CREAM [GERITREX CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [GERITREX CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-018CLOTRIMAZOLE CREAM [GERITREX CORP]1Legacy NDC, 1 package rows20140812_81811256-9c92-4c24-a662-d07b20a7f833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN81811256-9c92-4c24-a662-d07b20a7f8331
309367clotrimazole 10 MG/ML Topical CreamSCD81811256-9c92-4c24-a662-d07b20a7f8331
309367clotrimazole 1 % Topical CreamSY81811256-9c92-4c24-a662-d07b20a7f8331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54162-018-055416200180514 g in 1 TUBE14 gHistorical