Clobetasol Propionate (emollient)

Product NDC: 83148-064
Requested package NDC: 83148-064-30
11-digit product format: 831480064
Labeler code: 83148
Product ID: 83148-064_40290b7e-9b7d-6810-e063-6394a90a2d5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: The J. Molner Company LLC
Application: ANDA209411
Marketing category: ANDA
Marketing start: 2025-09-29
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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209411-001	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209411-001	AB2	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
26ccb1d8-c466-e238-e063-6394a90a0069	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83148-064-15	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	6
83148-064-15	Clobetasol Propionate (emollient)	15 g in 1 TUBE	CREAM	15	6
83148-064-30	Clobetasol Propionate (emollient)	30 g in 1 TUBE	CREAM	30	6
83148-064-30	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	6
83148-064-60	Clobetasol Propionate (emollient)	1 in 1 CARTON	CREAM	1	6
83148-064-60	Clobetasol Propionate (emollient)	60 g in 1 TUBE	CREAM	60	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83148-064-15	GM - Gram	83148-064	ac15e067-b249-4197-936a-1a0126d78a18	1	2025-10-14
83148-064-30	GM - Gram	83148-064	c916453a-bdc1-48b9-8970-84172605207e	1	2025-10-14
83148-064-60	GM - Gram	83148-064	34ca906f-a3aa-44b1-82f4-5559edef2061	1	2025-10-14

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 ndc (package): 83148-064-30 ndc (product): 83148-064 ndc11 (package): 83148006430

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	cb0bc057-d6ab-4eea-af7a-01661ae9b517	100
1992281	Emollient clobetasol propionate 0.5 MG/ML Topical Cream	SCD	cb0bc057-d6ab-4eea-af7a-01661ae9b517	100
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	SY	cb0bc057-d6ab-4eea-af7a-01661ae9b517	100
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	PSN	26ccb1d8-c466-e238-e063-6394a90a0069	6
1992281	Emollient clobetasol propionate 0.5 MG/ML Topical Cream	SCD	26ccb1d8-c466-e238-e063-6394a90a0069	6
1992281	clobetasol propionate 0.05 % Emollient Base Topical Cream	SY	26ccb1d8-c466-e238-e063-6394a90a0069	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83148-064-30	83148006430	1 TUBE in 1 CARTON (83148-064-30) / 30 g in 1 TUBE	1 tube	2025-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate (emollient)	Bryant Ranch Prepack	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	100
Clobetasol Propionate (emollient)	The J. Molner Company LLC \| Beach Products Inc. \| Groupe PARIMA Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	6