hydrocortisone acetate pramoxine hcl

Product NDC: 45802-144
11-digit product format: 458020144
Labeler code: 45802
Product ID: 45802-144_d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone acetate pramoxine hcl
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA085368
Marketing category: ANDA
Marketing start: 2010-04-13
Substance: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength: 1; 1 g/100g; g/100g
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: hydrocortisone acetate pramoxine hcl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	1 g/100g
PRAMOXINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1235049	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
9eea5875-d153-4bba-aee2-b1d1cd8b5e57	Available on FDA.report

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
45802-144-64	hydrocortisone acetate pramoxine hcl	1 in 1 CARTON	CREAM	1		5
45802-144-64	hydrocortisone acetate pramoxine hcl	28.35 g in 1 TUBE	CREAM	28.35		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-144-64	GM - Gram	45802-144	1d40c8cd-39cd-4587-8825-dd410e93aafc	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-144	HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	5	Current NDC, Legacy NDC, 2 package rows	20241218_9eea5875-d153-4bba-aee2-b1d1cd8b5e57.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 ndc (product): 45802-144

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
1235049	hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream	PSN	3c5e1833-9908-4e4f-bdf2-7a28c14a585c	104
1235049	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	3c5e1833-9908-4e4f-bdf2-7a28c14a585c	104
1235049	hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream	SY	3c5e1833-9908-4e4f-bdf2-7a28c14a585c	104
1235049	hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream	PSN	0c28458a-cc56-4eea-89aa-d60659bd9568	100
1235049	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	0c28458a-cc56-4eea-89aa-d60659bd9568	100
1235049	hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream	SY	0c28458a-cc56-4eea-89aa-d60659bd9568	100
1235049	hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream	PSN	9eea5875-d153-4bba-aee2-b1d1cd8b5e57	5
1235049	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	9eea5875-d153-4bba-aee2-b1d1cd8b5e57	5
1235049	hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream	SY	9eea5875-d153-4bba-aee2-b1d1cd8b5e57	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-144-64	45802014464	1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE	1 tube	2010-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream	Bryant Ranch Prepack	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	100
Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream	Bryant Ranch Prepack	2023-07-18	HUMAN PRESCRIPTION DRUG LABEL	104
Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream	Padagis Israel Pharmaceuticals Ltd	2022-05-31	HUMAN PRESCRIPTION DRUG LABEL	5