CLOTRIMAZOLE

Product NDC
70795-8020
11-digit product format
707958020
Labeler code
70795
Product ID
70795-8020_46d03d44-41ab-379e-e063-6394a90ab45d
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
GRAXCELL PHARMACEUTICAL, LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-08
Substance
CLOTRIMAZOLE
Active strength
1 g/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOTRIMAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65

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
70795-8020-12025-12-25C16284748780-11030e365-413c-111a-e063-dadaa90a10e2CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%
70795-8020-12024-01-30C16284748780-11030e365-413c-111a-e063-dadaa90a10e2CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-8020-1CLOTRIMAZOLE10 mL in 1 BOTTLESOLUTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-8020-1ML - Milliliter70795-80204d046d82-f5ce-4b9e-a6c6-b9bb0513c4ef12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70795-8020CLOTRIMAZOLE SOLUTION [GRAXCELL PHARMACEUTICAL, LLC.]13Current NDC, Legacy NDC, 1 package rows20211222_5f8ca6ad-cb25-1abf-e053-2a91aa0aca99.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70795-8020-17079580200110 mL in 1 BOTTLE (70795-8020-1) 10 ml2017-12-080000-00-00NoNoCurrent