Home NDC 51672-1308-3 Clotrimazole and Betamethasone Dipropionate
Product NDC 51672-1308
Requested package NDC 51672-1308-3
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076493-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB 2004-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076493-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% LOTION / TOPICAL AB RS 2004-07-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clotrimazole and Betamethasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE .5 mg/mL BETAMETHASONE DIPROPIONATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup 826Y60901U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308715 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1308-3 Clotrimazole and Betamethasone Dipropionate 1 in 1 CARTON LOTION 1 3 51672-1308-3 Clotrimazole and Betamethasone Dipropionate 30 mL in 1 BOTTLE LOTION 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Betamethasone Dipropionate ACTIVE INGREDIENT 826Y60901U CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 Clotrimazole ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 Betamethasone ACTIVE MOIETY 9842X06Q6M CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 Clotrimazole ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 ceteareth-30 INACTIVE INGREDIENT 1R9DCZ5FOX CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 mineral oil INACTIVE INGREDIENT T5L8T28FGP CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 petrolatum INACTIVE INGREDIENT 4T6H12BN9U CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 phosphoric acid INACTIVE INGREDIENT E4GA8884NN CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [PHYSICIANS TOTAL CARE, INC.] 4 Betamethasone Dipropionate ACTIVE INGREDIENT 826Y60901U CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 Clotrimazole ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 Betamethasone ACTIVE MOIETY 9842X06Q6M CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 Clotrimazole ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 ceteareth-30 INACTIVE INGREDIENT 1R9DCZ5FOX CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 phosphoric acid INACTIVE INGREDIENT E4GA8884NN CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 sodium phosphate, monobasic, anhydrous INACTIVE INGREDIENT KH7I04HPUU CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1308 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC, 2 package rows 20160519_e4e9f244-4a85-4c0d-9917-93182c4a6e87.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1308-3 51672130803 1 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLE 1 bottle 2004-07-28 0000-00-00 No No Current