FDA.reportPublic FDA data

Clotrimazole

Product NDC
51672-2002
11-digit product format
516722002
Labeler code
51672
Product ID
51672-2002_390cee55-c38f-accf-e063-6294a90ab7f7
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-06-01
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
Clotrimazole
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2002-1Clotrimazole15 g in 1 TUBECREAM154
51672-2002-1Clotrimazole1 in 1 CARTONCREAM14
51672-2002-2Clotrimazole30 g in 1 TUBECREAM304
51672-2002-2Clotrimazole1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2002CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20241115_a3a5cbf5-cabb-48d8-8877-74a97f7c0f57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 1 % Topical CreamPSN9afb964c-9b88-4701-adcf-7070e25cb6c17
309367clotrimazole 10 MG/ML Topical CreamSCD1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 10 MG/ML Topical CreamSCD9afb964c-9b88-4701-adcf-7070e25cb6c17
309367clotrimazole 1 % Topical CreamSY1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 1 % Topical CreamSY9afb964c-9b88-4701-adcf-7070e25cb6c17
309367clotrimazole 1 % Topical CreamPSNba1dc4a4-073f-4f30-bb9c-9ed0437004316
309367clotrimazole 10 MG/ML Topical CreamSCDba1dc4a4-073f-4f30-bb9c-9ed0437004316
309367clotrimazole 1 % Topical CreamSYba1dc4a4-073f-4f30-bb9c-9ed0437004316
309367clotrimazole 1 % Topical CreamPSN70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 10 MG/ML Topical CreamSCD70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 1 % Topical CreamSY70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 1 % Topical CreamPSNa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 10 MG/ML Topical CreamSCDa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 1 % Topical CreamSYa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 1 % Topical CreamPSNb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 1 % Topical CreamPSN01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 10 MG/ML Topical CreamSCDb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 10 MG/ML Topical CreamSCD01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 1 % Topical CreamSYb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 1 % Topical CreamSY01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 1 % Topical CreamPSN8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 1 % Topical CreamPSN8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 1 % Topical CreamPSNdeaa88bc-f7b0-16e2-e053-2995a90ac45a1
309367clotrimazole 10 MG/ML Topical CreamSCD8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 10 MG/ML Topical CreamSCD8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 10 MG/ML Topical CreamSCDdeaa88bc-f7b0-16e2-e053-2995a90ac45a1
309367clotrimazole 1 % Topical CreamSY8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 1 % Topical CreamSY8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 1 % Topical CreamSYdeaa88bc-f7b0-16e2-e053-2995a90ac45a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2002-1516722002011 TUBE in 1 CARTON (51672-2002-1) / 15 g in 1 TUBE1 tube1995-06-010000-00-00NoNoCurrent
51672-2002-2516722002021 TUBE in 1 CARTON (51672-2002-2) / 30 g in 1 TUBE1 tube1995-06-010000-00-00NoNoCurrent