Pramosone Cream

Product NDC: 54766-716
11-digit product format: 547660716
Labeler code: 54766
Product ID: 54766-716_431495fb-6225-9c16-e063-6394a90a14ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone acetate and pramoxine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Sebela Pharmaceuticals Inc.
Application: ANDA085368
Marketing category: ANDA
Marketing start: 2015-08-04
Marketing end: 2026-07-31
Substance: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength: 10; 10 mg/g; mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54766-716		D	Discontinued by firm	2026-08-03
excluded package	package	54766-716	54766-716-03	D	Discontinued by firm	2026-08-03
excluded package	package	54766-716	54766-716-04	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A085368-001	PRAMOSONE	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE	1%;1%	CREAM / TOPICAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085368-001	PRAMOSONE	1%;1%	CREAM / TOPICAL	Approved before 1982	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54766-716-03	Pramosone Cream	57 g in 1 TUBE	CREAM	57		4
54766-716-04	Pramosone Cream	28.4 g in 1 TUBE	CREAM	28.4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54766-716-03	GM - Gram	54766-716	c2f67530-3bd9-4b27-a916-e0b64c7e2d69	1	2015-09-10
54766-716-04	GM - Gram	54766-716	2d8b2e08-8531-4a66-8fe3-3fed184336f0	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
TROLAMINE LAURYL SULFATE	INACTIVE INGREDIENT	E8458C1KAA	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54766-716	PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20171215_3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b.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
Pramosone Cream	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	6a9fb75b-a2f7-4eca-8dce-d7eb5c122476	2025-06-30	Adverse reactions	Exact identifier application applno (ANDA): 085368 application number: ANDA085368
Analpram HC	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	39618fc5-87a8-47bc-93fc-cb97b8f663c8	2025-06-24	Adverse reactions	Exact identifier application applno (ANDA): 085368 application number: ANDA085368
hydrocortisone acetate pramoxine hcl	HYDROCORTISONE ACETATE PRAMOXINE HCL	Bryant Ranch Prepack	0c28458a-cc56-4eea-89aa-d60659bd9568	2023-08-17	Adverse reactions	Exact identifier application applno (ANDA): 085368 application number: ANDA085368
hydrocortisone acetate pramoxine hcl	HYDROCORTISONE ACETATE PRAMOXINE HCL	Bryant Ranch Prepack	3c5e1833-9908-4e4f-bdf2-7a28c14a585c	2023-07-18	Adverse reactions	Exact identifier application applno (ANDA): 085368 application number: ANDA085368
hydrocortisone acetate pramoxine hcl	HYDROCORTISONE ACETATE PRAMOXINE HCL	Padagis Israel Pharmaceuticals Ltd	9eea5875-d153-4bba-aee2-b1d1cd8b5e57	2022-05-31	Adverse reactions	Exact identifier application applno (ANDA): 085368 application number: ANDA085368

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116499	hydrocortisone acetate 1 % / pramoxine HCl 1 % Topical Cream	PSN	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4
1234519	Pramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical Cream	PSN	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4
1234519	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]	SBD	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4
1116499	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4
1116499	hydrocortisone acetate 1 % / pramoxine HCl 1 % Topical Cream	SY	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4
1234519	Pramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical Cream	SY	3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54766-716-03	54766071603	57 g in 1 TUBE (54766-716-03)	57 g	2015-08-04	2026-07-31	No	No	Current
54766-716-04	54766071604	28.4 g in 1 TUBE (54766-716-04)	28.4 g	2015-08-04	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%	Sebela Pharmaceuticals Inc. \| Ferndale Laboratories, Inc.	2025-11-08	HUMAN PRESCRIPTION DRUG LABEL	4