FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
51672-1308
11-digit product format
516721308
Labeler code
51672
Product ID
51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076493
Marketing category
ANDA
Marketing start
2004-07-28
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
.5; 10 mg/mL; mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole and Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/mL
CLOTRIMAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, G07GZ97H65
Rxcui308715

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1308-3Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONLOTION13
51672-1308-3Clotrimazole and Betamethasone Dipropionate30 mL in 1 BOTTLELOTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1308-3ML - Milliliter51672-1308b5125116-baf8-4947-beb3-c3816c51b18212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
BetamethasoneACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
ceteareth-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
mineral oilINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.]4
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
BetamethasoneACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
ceteareth-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium phosphate, monobasic, anhydrousINACTIVE INGREDIENTKH7I04HPUUCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1308CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 2 package rows20160519_e4e9f244-4a85-4c0d-9917-93182c4a6e87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN030a1460-3522-43af-a75d-29c99570698f4
308715clotrimazole 1 % / betamethasone dipropionate 0.05 % Topical LotionPSN030a1460-3522-43af-a75d-29c99570698f4
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD030a1460-3522-43af-a75d-29c99570698f4
308715betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical LotionSCD030a1460-3522-43af-a75d-29c99570698f4
308715betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / clotrimazole 1 % Topical LotionSY030a1460-3522-43af-a75d-29c99570698f4
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY030a1460-3522-43af-a75d-29c99570698f4
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY030a1460-3522-43af-a75d-29c99570698f4
308715clotrimazole 1 % / betamethasone dipropionate 0.05 % Topical LotionPSNe4e9f244-4a85-4c0d-9917-93182c4a6e873
308715betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical LotionSCDe4e9f244-4a85-4c0d-9917-93182c4a6e873
308715betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / clotrimazole 1 % Topical LotionSYe4e9f244-4a85-4c0d-9917-93182c4a6e873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1308-3516721308031 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLE1 bottle2004-07-280000-00-00NoNoCurrent