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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-1308DDiscontinued by firm2026-08-07
excluded packagepackage51672-130851672-1308-3DDiscontinued by firm2026-08-07

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-1308-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-1308-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51672-1308-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51672-1308-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51672-1308-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51672-1308-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51672-1308-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51672-1308-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51672-1308-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51672-1308-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51672-1308-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51672-1308-3557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076493-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALAB2004-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076493-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%LOTION / TOPICALABRS2004-07-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076493-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076493-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076493-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076493-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076493-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076493-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076493-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076493-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076493-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076493-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076493-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076493-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076493-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076493-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076493-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076493-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076493-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076493-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076493-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076493-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076493-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076493-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076493-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076493-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076493-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076493-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076493-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076493-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076493-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076493-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076493-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076493-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076493-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076493-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076493-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076493-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076493-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076493-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076493-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076493-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.5 mg/mL
BETAMETHASONE DIPROPIONATE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup
826Y60901UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308715Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4e9f244-4a85-4c0d-9917-93182c4a6e87Available on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.e4e9f244-4a85-4c0d-9917-93182c4a6e872025-07-07Adverse reactionsExact identifier
application applno (ANDA): 076493
application number: ANDA076493
ndc (product): 51672-1308

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