Clobetasol Propionate (emollient)

Product NDC: 52565-094
Requested package NDC: 52565-094-60
11-digit product format: 525650094
Labeler code: 52565
Product ID: 52565-094_ead40d2f-5094-43d1-bcf0-bb8568dea064
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA209411
Marketing category: ANDA
Marketing start: 2017-08-21
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-094	52565-094-60	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB2		2017-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209411-001	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 · 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	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209411-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209411-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209411-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209411-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209411-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209411-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209411-001	AB2	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209411-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209411-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209411-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209411-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209411-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209411-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209411-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209411-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209411-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209411-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209411-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209411-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209411-001	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209411-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209411-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209411-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209411-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209411-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209411-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209411-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209411-001	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209411-001	AB2	1	`a50c72e98297…`

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, Related label table
NDC	Related label
52565-094-15	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-30	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-45	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-60	These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-094-15	Clobetasol Propionate (emollient)	15 g in 1 TUBE	CREAM	15	2
52565-094-15	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	2
52565-094-30	Clobetasol Propionate (emollient)	30 g in 1 TUBE	CREAM	30	2
52565-094-30	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	2
52565-094-45	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	2
52565-094-45	Clobetasol Propionate (emollient)	45 g in 1 TUBE	CREAM	45	2
52565-094-60	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	2
52565-094-60	Clobetasol Propionate (emollient)	60 g in 1 TUBE	CREAM	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-094-15	GM - Gram	52565-094	e6b79ff4-c55e-40b1-a033-7824ba9227ad	1	2017-11-06
52565-094-30	GM - Gram	52565-094	25c9b26c-1664-4f10-895e-2adb04b8a14b	1	2017-11-06
52565-094-45	GM - Gram	52565-094	62255d49-07a6-4607-8766-401fe2411f3c	1	2017-11-06
52565-094-60	GM - Gram	52565-094	1244db96-89a9-459d-b308-3a759497895e	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-094	CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [TELIGENT PHARMA, INC.]	2	Legacy NDC, 8 package rows	20190911_a175ba8a-a037-d62c-977a-96e2a776f7b1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	cb0bc057-d6ab-4eea-af7a-01661ae9b517	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209411 application number: ANDA209411
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	The J. Molner Company LLC	26ccb1d8-c466-e238-e063-6394a90a0069	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209411 application number: ANDA209411

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	a175ba8a-a037-d62c-977a-96e2a776f7b1	2
1992281	Emollient clobetasol propionate 0.5 MG/ML Topical Cream	SCD	a175ba8a-a037-d62c-977a-96e2a776f7b1	2
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	SY	a175ba8a-a037-d62c-977a-96e2a776f7b1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-094-60	52565009460	1 TUBE in 1 CARTON (52565-094-60) > 60 g in 1 TUBE	1 tube	2017-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate (emollient)	Teligent Pharma, Inc.	2017-08-21	HUMAN PRESCRIPTION DRUG LABEL	2