Clotrimazole and Betamethasone Dipropionate

Product NDC: 0472-0379
11-digit product format: 004720379
Labeler code: 0472
Product ID: 0472-0379_6ecf0409-4072-415c-8381-658cce80bc76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole and Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076002
Marketing category: ANDA
Marketing start: 2003-12-16
Substance: BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength: .5; 10 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2002-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076002-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076002-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076002-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076002-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076002-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076002-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076002-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076002-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076002-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076002-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076002-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076002-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076002-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076002-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076002-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076002-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076002-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076002-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076002-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076002-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076002-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076002-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076002-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076002-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076002-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076002-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076002-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076002-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076002-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076002-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076002-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076002-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076002-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076002-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076002-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076002-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076002-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076002-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076002-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076002-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076002-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clotrimazole and Betamethasone Dipropionate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	.5 mg/g
BETAMETHASONE DIPROPIONATE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup
826Y60901U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308714	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
a6ac4020-2c67-426a-8289-7e54ce43d0c9	Available on FDA.report

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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
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
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0472-0379-15	Clotrimazole and Betamethasone Dipropionate	1 in 1 CARTON	CREAM	1		15
0472-0379-15	Clotrimazole and Betamethasone Dipropionate	15 g in 1 TUBE	CREAM	15		15
0472-0379-45	Clotrimazole and Betamethasone Dipropionate	1 in 1 CARTON	CREAM	1		15
0472-0379-45	Clotrimazole and Betamethasone Dipropionate	45 g in 1 TUBE	CREAM	45		15
0472-0379-15	DermacinRx Therazole Pak	15 g in 1 TUBE	CREAM	15 g	10 mg in 1g	5
0472-0379-15	DermacinRx Therazole Pak	1 in 1 CARTON	CREAM		10 mg in 1g	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0379-15	GM - Gram	0472-0379	ecfd98e3-c2c4-4ced-b09e-e91636e3add6	1	2012-07-24
0472-0379-45	GM - Gram	0472-0379	c59be4f7-0c6c-4bce-b96d-c9fb98768007	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
CETEARETH-30	INACTIVE INGREDIENT	1R9DCZ5FOX	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]	2
betamethasone dipropionate	ACTIVE INGREDIENT	826Y60901U	BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]	1
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]	1
betamethasone	ACTIVE MOIETY	9842X06Q6M	BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]	1
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
clotrimazole	ACTIVE MOIETY	G07GZ97H65	BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
CETEARETH-30	INACTIVE INGREDIENT	1R9DCZ5FOX	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0379	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]	13	Current NDC, Legacy NDC, 4 package rows	20241116_a6ac4020-2c67-426a-8289-7e54ce43d0c9.zip
0472-0379	DERMACINRX THERAZOLE PAK (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE) KIT [PURETEK CORPORATION]	5	Current NDC, Legacy NDC	20241215_c47f8a9c-9c86-4068-814e-05ab2090d19e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole/Betameth	CLOTRIMAZOLE/BETAMETH	Direct_Rx	08901233-7d36-e5d9-e063-6394a90af33d	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	153fed41-6662-4ca9-802f-84b44dcb65e9	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	a6ac4020-2c67-426a-8289-7e54ce43d0c9	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002 ndc (product): 0472-0379
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	5ca32ede-b546-4b65-90d6-c69add760522	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	3d235926-6f17-4aa5-be82-7f1b4357e247	2022-06-01	Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	153fed41-6662-4ca9-802f-84b44dcb65e9	105
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	153fed41-6662-4ca9-802f-84b44dcb65e9	105
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	153fed41-6662-4ca9-802f-84b44dcb65e9	105
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	153fed41-6662-4ca9-802f-84b44dcb65e9	105
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	a6ac4020-2c67-426a-8289-7e54ce43d0c9	15
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	a6ac4020-2c67-426a-8289-7e54ce43d0c9	15
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	a6ac4020-2c67-426a-8289-7e54ce43d0c9	15
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	a6ac4020-2c67-426a-8289-7e54ce43d0c9	15
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	5ca32ede-b546-4b65-90d6-c69add760522	10
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	5ca32ede-b546-4b65-90d6-c69add760522	10
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	5ca32ede-b546-4b65-90d6-c69add760522	10
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	5ca32ede-b546-4b65-90d6-c69add760522	10
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	3d235926-6f17-4aa5-be82-7f1b4357e247	7
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	3d235926-6f17-4aa5-be82-7f1b4357e247	7
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	3d235926-6f17-4aa5-be82-7f1b4357e247	7
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	3d235926-6f17-4aa5-be82-7f1b4357e247	7
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 20 % Topical Paste	PSN	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 0.2 MG/MG Paste	SCD	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 20 % Topical Paste	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	ZNO 0.2 MG/MG Paste	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	08901233-7d36-e5d9-e063-6394a90af33d	3
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	08901233-7d36-e5d9-e063-6394a90af33d	3
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	08901233-7d36-e5d9-e063-6394a90af33d	3
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	08901233-7d36-e5d9-e063-6394a90af33d	3
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	1f6b6287-6b86-45f5-a56b-93204a67e2f5	1
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	de6a1bb4-0a69-4cdc-bc41-d8c62e403599	1
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	e947a6be-90ae-40d8-b9dd-afa14a66bb9d	1
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	1f6b6287-6b86-45f5-a56b-93204a67e2f5	1
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	de6a1bb4-0a69-4cdc-bc41-d8c62e403599	1
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	e947a6be-90ae-40d8-b9dd-afa14a66bb9d	1
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	1f6b6287-6b86-45f5-a56b-93204a67e2f5	1
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	de6a1bb4-0a69-4cdc-bc41-d8c62e403599	1
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	e947a6be-90ae-40d8-b9dd-afa14a66bb9d	1
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	1f6b6287-6b86-45f5-a56b-93204a67e2f5	1
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	de6a1bb4-0a69-4cdc-bc41-d8c62e403599	1
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	e947a6be-90ae-40d8-b9dd-afa14a66bb9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0379-15	00472037915	1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE	1 tube	2003-12-16	0000-00-00	No	No	Current
0472-0379-45	00472037945	1 TUBE in 1 CARTON (0472-0379-45) / 45 g in 1 TUBE	1 tube	2003-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole/Betameth	Direct_Rx	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	3
Clotrimazole and Betamethasone Dipropionate	Bryant Ranch Prepack	2025-09-09	HUMAN PRESCRIPTION DRUG LABEL	105
DermacinRx Therazole Pak	PureTek Corporation	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	5
Clotrimazole and Betamethasone Dipropionate	Actavis Pharma, Inc.	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	13
Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	2
Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	2023-09-28	HUMAN PRESCRIPTION DRUG LABEL	10
Clotrimazole and Betamethasone Dipropionate Cream USP	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	7
Ciclomazole	PureTek Corporation \| PERRIGO NEW YORK INC \| G&W NC Laboratories, LLC	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL	1
Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	2019-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	2018-10-23	HUMAN PRESCRIPTION DRUG LABEL	1
Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	2018-05-31	HUMAN PRESCRIPTION DRUG LABEL	1
clotrimazole and betamethasone dipropionate	NuCare Pharamceuticals,Inc. \| NuCare Pharamaceuticals,Inc.	2017-09-08	HUMAN PRESCRIPTION DRUG LABEL	1
clotrimazole and betamethasone dipropionate	NuCare Pharmaceuticals,Inc.	2017-09-06	HUMAN PRESCRIPTION DRUG LABEL	1
clotrimazole and betamethasone dipropionate	NuCare Pharmaceuticals,Inc.	2017-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream	Stat Rx USA	2009-10-27	HUMAN PRESCRIPTION DRUG LABEL	1