FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
0168-0258
11-digit product format
001680258
Labeler code
0168
Product ID
0168-0258_e327c963-4ef7-4521-8a53-0c249cd21857
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA075502
Marketing category
ANDA
Marketing start
2001-06-05
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
.5; 10 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 6 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 packagepackage0168-0258-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0168-0258-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0258-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0258-46f5e01cc5f278…a2eaf40c39c3…

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
A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075502-001AB

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 UTC2026-02A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075502-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-06-05cb3db0bc1861…

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 UTC2026-02A075502-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075502-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075502-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075502-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075502-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075502-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075502-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075502-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075502-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075502-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075502-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075502-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075502-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075502-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075502-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075502-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075502-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075502-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075502-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075502-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075502-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075502-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075502-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075502-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075502-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075502-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075502-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075502-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075502-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075502-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075502-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075502-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075502-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075502-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075502-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075502-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075502-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075502-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075502-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075502-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole and Betamethasone Dipropionate
Listing expiration
2027-12-31

Active Ingredients#

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

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
308714Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55db730a-df6d-4950-9c26-91b06bdcef36Available 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0168-0258-152025-07-29These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-152025-07-29These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462025-07-29These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462025-07-29These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-152020-09-17These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-152020-09-17These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462020-09-17These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462020-09-17These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-152020-07-22These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-152020-07-22These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462020-07-22These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984
0168-0258-462020-07-22These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0258-15Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM1514
0168-0258-46Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0258-15GM - Gram0168-02586bca82ca-e8b1-4f8d-baba-fe20d61a962012012-07-24
0168-0258-46GM - Gram0168-0258bc352828-349e-4f05-86c3-780d0ccfa98312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
clotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
BETAMETHASONEACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
clotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0258CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 2 package rows20200918_55db730a-df6d-4950-9c26-91b06bdcef36.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 DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC55db730a-df6d-4950-9c26-91b06bdcef362026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075502
application number: ANDA075502
ndc (product): 0168-0258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY55db730a-df6d-4950-9c26-91b06bdcef3614
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY38ac6015-3823-48a2-a02c-433ccaeaf7854
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYf82ff62b-96a1-4b9c-80f6-c17192f6bbd02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0258-150016802581515 g in 1 TUBE (0168-0258-15) 15 g2001-06-050000-00-00NoNoCurrent
0168-0258-460016802584645 g in 1 TUBE (0168-0258-46) 45 g2001-06-050000-00-00NoNoCurrent