Clotrimazole

Product NDC
50382-025
Requested package NDC
50382-025-13
11-digit product format
503820025
Labeler code
50382
Product ID
50382-025_ee867ca4-3bf8-a838-e053-2a95a90abb80
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-07
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50382-025-13503820025131 TUBE in 1 CARTON (50382-025-13) > 28 g in 1 TUBE1 tube2013-08-070000-00-00NoNoCurrent