Temovate

Product NDC: 10337-163
11-digit product format: 103370163
Labeler code: 10337
Product ID: 10337-163_17dbbb71-8c20-449c-aa10-67b7d40aee18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application: ANDA074392
Marketing category: ANDA
Marketing start: 1996-09-30
Marketing end: 2022-06-30
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10337-163		D	Discontinued by firm	2026-08-03
excluded package	package	10337-163	10337-163-30	D	Discontinued by firm	2026-08-03
excluded package	package	10337-163	10337-163-60	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10337-163-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10337-163-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10337-163-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10337-163-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10337-163-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10337-163-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10337-163-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10337-163-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10337-163-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10337-163-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10337-163-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10337-163-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10337-163-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10337-163-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10337-163-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10337-163-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10337-163-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10337-163-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10337-163-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10337-163-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10337-163-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10337-163-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10337-163-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10337-163-30	`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
A074392-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		1996-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074392-001	AB1

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074392-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074392-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074392-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074392-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074392-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074392-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074392-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074392-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074392-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074392-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074392-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074392-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074392-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074392-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074392-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074392-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074392-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074392-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074392-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074392-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074392-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074392-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074392-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074392-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074392-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074392-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074392-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074392-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074392-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074392-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074392-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074392-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074392-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074392-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074392-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074392-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074392-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074392-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074392-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074392-001	AB1	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10337-163-30	2020-09-21	TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%
10337-163-60	2020-09-21	TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%
10337-163-30	2020-07-22	TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%
10337-163-60	2020-07-22	TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10337-163-30	GM - Gram	10337-163	c2d0ff69-659b-4203-b93b-c60c5e09eb9e	1	2013-10-17
10337-163-60	GM - Gram	10337-163	ece30a51-0252-4ab8-8615-0047e1cb2476	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clobetasol propionate	ACTIVE INGREDIENT	779619577M	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
clobetasol	ACTIVE MOIETY	ADN79D536H	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
chlorocresol	INACTIVE INGREDIENT	36W53O7109	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
sorbitan sesquioleate	INACTIVE INGREDIENT	0W8RRI5W5A	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
white wax	INACTIVE INGREDIENT	7G1J5DA97F	TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2d4fa3a3-dc1c-4d3c-9959-4751e09d25be	2025-07-08	Adverse reactions	Exact identifier application applno (ANDA): 074392 application number: ANDA074392
Clobetasol Propionate	CLOBETASOL PROPIONATE	Proficient Rx LP	e0f7bc85-9c13-44df-9b37-c216ecfe3ffe	2024-03-01	Adverse reactions	Exact identifier application applno (ANDA): 074392 application number: ANDA074392

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10337-163-30	10337016330	1 TUBE in 1 CARTON (10337-163-30) > 30 g in 1 TUBE	1 tube	1996-09-30	2022-06-30	No	No	Current
10337-163-60	10337016360	1 TUBE in 1 CARTON (10337-163-60) > 60 g in 1 TUBE	1 tube	1996-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%	PharmaDerm a division of Fougera Pharmaceuticals Inc.	2022-03-07	HUMAN PRESCRIPTION DRUG LABEL	8