Clobetasol Propionate Spray, 0.05%

Manufacturer: Zydus Lifesciences Limited
Effective date: 2026-10-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: daily-update
Hydrated at: 2026-10-09 01:03:55

Label at a glance#

Productclobetasol propionate

Active ingredientCLOBETASOL PROPIONATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clobetasol Propionate Topical Spray USP, 0.05%

NDC 70771-1080-6

2 fl. oz. (59 mL)

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0368382998019	GTIN-13: 0368382998019 EAN-13: 0368382998019 GTIN-12: 368382998019 UPC-A: 368382998019 GTIN storage (14 digits): 00368382998019	91dd35e1-5789-4267-b124-195ab2630c60-01.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

clobetasol propionate
CLOBETASOL
ALCOHOL
ISOPROPYL MYRISTATE
SODIUM LAURYL SULFATE
UNDECYLENIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1080	70771-1080-7, 70771-1080-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOBETASOL PROPIONATE	779619577M	ACTIB
ALCOHOL	3K9958V90M	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
UNDECYLENIC ACID	K3D86KJ24N	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2024-11-26	full-release	2026-05-31 21:18:21

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 44.

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
A206378-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT		2017-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206378-001	AT

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 · 44 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
2026-10-15 13:18:30	2026-09	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206378-001	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	2017-02-16	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206378-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206378-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206378-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206378-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206378-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206378-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206378-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206378-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206378-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206378-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206378-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206378-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206378-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206378-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206378-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206378-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206378-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206378-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206378-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206378-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206378-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206378-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206378-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206378-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206378-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206378-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206378-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206378-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206378-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206378-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206378-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206378-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206378-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206378-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206378-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206378-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206378-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206378-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206378-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206378-001	AT	1	`3a93d1ddd44b…`

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
5aa7859e-8672-48ae-8116-cc6a012115c7			287ce325-4449-4342-a9ef-a7e31ee692bd	2024-11-26		Exact identifier spl set id: 287ce325-4449-4342-a9ef-a7e31ee692bd

Reported adverse events (FAERS/openFDA)#

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