Clobetasol Propionate (emollient)

Product NDC: 0168-0301
11-digit product format: 001680301
Labeler code: 0168
Product ID: 0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application: ANDA075430
Marketing category: ANDA
Marketing start: 1999-05-26
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075430-001	AB2

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 · 42 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
2026-08-18 06:07:40	2026-07	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075430-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	RS	1999-05-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075430-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075430-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075430-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075430-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075430-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075430-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075430-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075430-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075430-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075430-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075430-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075430-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075430-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075430-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075430-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075430-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075430-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075430-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075430-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075430-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075430-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075430-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075430-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075430-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075430-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075430-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075430-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075430-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075430-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075430-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075430-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075430-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075430-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075430-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075430-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075430-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075430-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075430-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075430-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075430-001	AB2	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clobetasol Propionate (emollient)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBETASOL PROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
779619577M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1992281	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20abe2c3-3e80-d2b2-39eb-3156e4af4799	Product name	3	20250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6f	Product name	1	20250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571df	Product name	7	20250107
3813b789-94b9-edd6-f010-6b926dd462e5	Product name	5	20230113
30eee8a1-850e-41ed-b5ab-761301aeab49	Product name	6	20221206
18e5b6f7-c414-b1f1-b684-17fdd02c215e	Product name	4	20210927
1c87bbde-dd91-a122-db33-67ae814cb645	Product name	7	20210510
519b5875-7d7d-4aa6-9d3d-470fa1376595	Product name	4	20200227
98669154-3e9c-47da-8a2c-656ab71848be	Product name	2	20180607
8d4f8539-436f-453b-8b76-5322d403fc8e	Product name	1	20180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5	Product name	2	20171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0168-0301-15	2020-09-16	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-30	2020-09-16	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-60	2020-09-16	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-15	2020-07-22	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-30	2020-07-22	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-60	2020-07-22	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0168-0301-15	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	10
0168-0301-15	Clobetasol Propionate (emollient)	15 g in 1 TUBE	CREAM	15	10
0168-0301-30	Clobetasol Propionate (emollient)	30 g in 1 TUBE	CREAM	30	10
0168-0301-30	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	10
0168-0301-60	Clobetasol Propionate (emollient)	60 g in 1 TUBE	CREAM	60	10
0168-0301-60	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0301-15	GM - Gram	0168-0301	2970c874-5a51-4e83-ada8-09c3b7d8d18d	1	2012-07-24
0168-0301-30	GM - Gram	0168-0301	8a5648af-fe50-42bb-96ea-e6d3f858614f	1	2012-07-24
0168-0301-60	GM - Gram	0168-0301	7ddbef40-e047-4dff-b94a-4f6dfbfa50bf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clobetasol propionate	ACTIVE INGREDIENT	779619577M	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
clobetasol	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
ceteth-20	INACTIVE INGREDIENT	I835H2IHHX	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
dimethicone 350	INACTIVE INGREDIENT	2Y53S6ATLU	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
imidurea	INACTIVE INGREDIENT	M629807ATL	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0301	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 6 package rows	20220112_fdfd83ee-dfb4-4c12-a74e-a0053e34e08c.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075430 application number: ANDA075430 ndc (product): 0168-0301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
779619577M	CLOBETASOL PROPIONATE	25122-46-7	CLOBETASOL PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	PSN	fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	10
1992281	Emollient clobetasol propionate 0.5 MG/ML Topical Cream	SCD	fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	10
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	SY	fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0168-0301-15	00168030115	1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE	1 tube	1999-05-26	0000-00-00	No	No	Current
0168-0301-30	00168030130	1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE	1 tube	1999-05-26	0000-00-00	No	No	Current
0168-0301-60	00168030160	1 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE	1 tube	1999-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate (emollient)	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2021-07-01	HUMAN PRESCRIPTION DRUG LABEL	10