FDA.reportPublic FDA data

ANTIFUNGAL

Product NDC
21922-094
11-digit product format
219220094
Labeler code
21922
Product ID
21922-094_c9cf3a99-2b28-49c8-85f9-f693ca847074
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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
21922-094-04ANTIFUNGAL1 in 1 CARTONCREAM12
21922-094-04ANTIFUNGAL14 g in 1 TUBECREAM142
21922-094-05ANTIFUNGAL1 in 1 CARTONCREAM12
21922-094-05ANTIFUNGAL28 g in 1 TUBECREAM282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-094-04GM - Gram21922-09413c92971-15bc-4ff1-abc6-10068e73b5fb12025-11-13
21922-094-05GM - Gram21922-094b10723ba-4f02-448b-ba85-7587d502c65b12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-094ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 4 package rows20250308_afbc28f8-bb76-424d-9d73-136e6c283ead.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNafbc28f8-bb76-424d-9d73-136e6c283ead2
309367clotrimazole 10 MG/ML Topical CreamSCDafbc28f8-bb76-424d-9d73-136e6c283ead2
309367clotrimazole 1 % Topical CreamSYafbc28f8-bb76-424d-9d73-136e6c283ead2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-094-04219220094041 TUBE in 1 CARTON (21922-094-04) / 14 g in 1 TUBE1 tube2025-03-06NoNoCurrent
21922-094-05219220094051 TUBE in 1 CARTON (21922-094-05) / 28 g in 1 TUBE1 tube2025-03-06NoNoCurrent