Clotrimazole and Betamethasone Dipropionate

Product NDC: 53002-9740
11-digit product format: 530029740
Labeler code: 53002
Product ID: 53002-9740_e98def49-c684-4258-8593-d86a2d46c020
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole and Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA202894
Marketing category: ANDA
Marketing start: 2015-11-06
Marketing end: 0000-00-00
Substance: BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength: 1 mg/g; mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-9740		I	Inactivated by FDA		2026-10-05
excluded package	package	53002-9740	53002-9740-1	I	Inactivated by FDA		2026-10-05

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-9740-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-9740-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-9740-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-9740-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-9740-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-9740-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-9740-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-9740-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-9740-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-9740-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-9740-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-9740-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-9740-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-9740-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-9740-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53002-9740-1	E	Excluded after deficient or non-compliant submission was not corrected	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-9740-1	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-9740-1	Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`

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
A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL			2015-10-30

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	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A202894-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202894-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202894-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-9740-1	2023-01-30	C162847	48780-1	f386c649-f2fe-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream, USP, for topical use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-9740-1	Clotrimazole and Betamethasone Dipropionate	15 g in 1 TUBE	CREAM	15		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-9740	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [RPK PHARMACEUTICALS, INC.]	6	Legacy NDC, 1 package rows	20220129_756180ee-4df5-4c02-8657-8d9882991036.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Direct Rx	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	c6e4bf5f-f6d6-489e-9286-c30568c601b7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc. USA	8dcd24cb-e568-428a-88ac-737d115cc54d	2020-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-9740-1	53002974001	15 g in 1 TUBE (53002-9740-1)	15 g	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	2021-05-05	HUMAN PRESCRIPTION DRUG LABEL	6