CLOBETASOL PROPIONATE lotion, 0.05%

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 21:10:45

Label at a glance#

ProductClobetasol Propionate

Active ingredientCLOBETASOL PROPIONATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1498-7

Clobetasol Propionate Lotion, 0.05%

Rx only

118 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
861505	clobetasol propionate 0.05 % Topical Lotion	PSN	4
861505	clobetasol propionate 0.5 MG/ML Topical Lotion	SCD	4
861505	clobetasol propionate 0.05 % Topical Lotion	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CLOBETASOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1498-6	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	4
70771-1498-6	Clobetasol Propionate	59 mL in 1 BOTTLE	LOTION	59	4
70771-1498-7	Clobetasol Propionate	118 mL in 1 BOTTLE	LOTION	118	4
70771-1498-7	Clobetasol Propionate	1 in 1 CARTON	LOTION	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1498	CLOBETASOL PROPIONATE LOTION [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 4 package rows	20240817_d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Clobetasol Propionate
CLOBETASOL
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
GLYCERYL STEARATE/PEG-100 STEARATE
MINERAL OIL
PEG-6 ISOSTEARATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1498	70771-1498-7, 70771-1498-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOBETASOL PROPIONATE	779619577M	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
GLYCERYL STEARATE/PEG-100 STEARATE	RD25J5V947	IACT
MINERAL OIL	T5L8T28FGP	IACT
PEG-6 ISOSTEARATE	0E2639OTJY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A205249-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB		2019-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205249-001	AB

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
2026-09-14 22:38:34	2026-08	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205249-001	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	2019-09-24	`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
2026-09-14 22:38:34	2026-08	A205249-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205249-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205249-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205249-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205249-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205249-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205249-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205249-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205249-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205249-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205249-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205249-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205249-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205249-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205249-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205249-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205249-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205249-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205249-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205249-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205249-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205249-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205249-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205249-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205249-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205249-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205249-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205249-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205249-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205249-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205249-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205249-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205249-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205249-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205249-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205249-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205249-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205249-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205249-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205249-001	AB	1	`cb3db0bc1861…`

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	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb	2024-08-14		Exact identifier ndc (package): 70771-1498-6 ndc (package): 70771-1498-7 ndc (product): 70771-1498 ndc11 (package): 70771149807 ndc11 (package): 70771149806 spl id: 9f450773-f504-4f0e-bebe-30a95b7fce93 spl set id: d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb

Reported adverse events (FAERS/openFDA)#

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