Clotrimazole

Product NDC
0536-1181
11-digit product format
005361181
Labeler code
0536
Product ID
0536-1181_4653182f-1c24-b29e-e063-6294a90a955b
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
RUGBY LABORATORIES
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-20
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1181-70Clotrimazole10 mL in 1 BOTTLESOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1181-70ML - Milliliter0536-11815fd2c30f-feb7-468c-819e-bdad1d3bdf9912019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1181CLOTRIMAZOLE SOLUTION [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 1 package rows20241120_6de9155b-7070-38fd-e053-2a91aa0af6f6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1181-700053611817010 mL in 1 BOTTLE (0536-1181-70) 10 ml2018-08-200000-00-00NoNoCurrent