FifthPulse clotrimazole cream 4oz

Product NDC
69571-019
11-digit product format
695710019
Labeler code
69571
Product ID
69571-019_3a389093-48f3-29cb-e063-6294a90ada37
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Front Pharmaceutical PLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-19
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
FifthPulse clotrimazole cream 4oz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

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
69571-019-01FifthPulse clotrimazole cream 4oz113.4 g in 1 TUBECREAM113.41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN3a389093-48f2-29cb-e063-6294a90ada371
309367clotrimazole 10 MG/ML Topical CreamSCD3a389093-48f2-29cb-e063-6294a90ada371
309367clotrimazole 1 % Topical CreamSY3a389093-48f2-29cb-e063-6294a90ada371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69571-019-0169571001901113.4 g in 1 TUBE (69571-019-01) 113.4 g2025-07-19NoNoCurrent