DIPROLENE

Product NDC: 78206-124
11-digit product format: 782060124
Labeler code: 78206
Product ID: 78206-124_35f40d2c-b958-4c7a-88b1-47b1790996ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: betamethasone dipropionate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Organon LLC
Application: NDA018741
Marketing category: NDA
Marketing start: 2021-06-01
Substance: BETAMETHASONE DIPROPIONATE
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 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
N018741-001	DIPROLENE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018741-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018741-001	DIPROLENE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	RLD, RS	1983-07-27	`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	N018741-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018741-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018741-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018741-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018741-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018741-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018741-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018741-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018741-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018741-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018741-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018741-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018741-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018741-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018741-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018741-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018741-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018741-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018741-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018741-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018741-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018741-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018741-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018741-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018741-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018741-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018741-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018741-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018741-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018741-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018741-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018741-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018741-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018741-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018741-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018741-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018741-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018741-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018741-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018741-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: DIPROLENE
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848180	Internal RxNorm lookup
848200	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
0b9543ad-2ca7-430d-aef9-81c376dc2e6c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
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
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78206-124-01	DIPROLENE	1 in 1 BOX	OINTMENT	1	3
78206-124-01	DIPROLENE	15 g in 1 TUBE	OINTMENT	15	3
78206-124-02	DIPROLENE	1 in 1 BOX	OINTMENT	1	3
78206-124-02	DIPROLENE	50 g in 1 TUBE	OINTMENT	50	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-124-01	GM - Gram	78206-124	342a2698-af17-464d-b7a3-2ce6b8b9d900	1	2021-10-08
78206-124-02	GM - Gram	78206-124	f1a0e34b-0bf0-44e8-829d-4cfe40a284f6	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-124	DIPROLENE (BETAMETHASONE DIPROPIONATE) OINTMENT [ORGANON LLC]	2	Current NDC, Legacy NDC, 4 package rows	20220408_0b9543ad-2ca7-430d-aef9-81c376dc2e6c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Prasco Laboratories	f5b50c00-cc6f-4296-a9ae-b16888cef4dd	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018741 application number: NDA018741
DIPROLENE	BETAMETHASONE DIPROPIONATE	Organon LLC	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018741 application number: NDA018741 ndc (product): 78206-124

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848180	betamethasone dipropionate 0.05 % Augmented Topical Ointment	PSN	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Diprolene 0.05 % Topical Ointment	PSN	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Augmented betamethasone 0.0005 MG/MG Topical Ointment [Diprolene]	SBD	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848180	Augmented betamethasone 0.0005 MG/MG Topical Ointment	SCD	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848180	augmented betamethasone 0.05 % Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Augmented Diprolene 0.0005 MG/MG Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848180	betamethasone 0.05 % Augmented Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848180	betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Diprolene (betamethasone dipropionate) 0.05 % Augmented Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Diprolene 0.0005 MG/MG Augmented Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3
848200	Diprolene 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Augmented Topical Ointment	SY	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-124-01	78206012401	1 TUBE in 1 BOX (78206-124-01) / 15 g in 1 TUBE	1 tube	2021-06-01	0000-00-00	No	No	Current
78206-124-02	78206012402	1 TUBE in 1 BOX (78206-124-02) / 50 g in 1 TUBE	1 tube	2021-06-01	0000-00-00	No	No	Current