EPIFOAM

Product NDC
0037-6824
11-digit product format
000376824
Labeler code
0037
Product ID
0037-6824_c99db232-5398-45ed-a621-83448f51f5ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramoxine hydrochloride and hydrocortisone acetate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Viatris Specialty LLC
Application
ANDA086457
Marketing category
ANDA
Marketing start
2014-08-25
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
100; 100 mg/10g; mg/10g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086457-001EPIFOAMHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A086457-001BX

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086457-001EPIFOAM1%;1%AEROSOL, METERED / TOPICALBXApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A086457-001BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086457-001BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086457-001BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086457-001BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086457-001BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086457-001BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086457-001BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086457-001BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086457-001BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086457-001BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086457-001BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086457-001BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086457-001BX11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086457-001BX18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086457-001BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086457-001BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086457-001BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086457-001BX174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086457-001BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086457-001BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086457-001BX187673890dc5c…
2021-03-12 10:30 UTC2021-03A086457-001BX15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086457-001BX18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086457-001BX1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086457-001BX13f01610625f2…
2019-09-15 20:21 UTC2019-09A086457-001BX1b00525d2431f…
2019-07-19 19:46 UTC2019-07A086457-001BX1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086457-001BX16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086457-001BX11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086457-001BX1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086457-001BX1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086457-001BX19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086457-001BX1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086457-001BX13f0d92c62455…
2023-05-13 08:27 UTC2023-05A086457-001BX1053a50430f4f…
2023-01-26 05:58 UTC2023-01A086457-001BX13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086457-001BX13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086457-001BX1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086457-001BX1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086457-001BX1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE100 mg/10g
HYDROCORTISONE ACETATE100 mg/10g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904782Internal RxNorm lookup
904783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b22b8b41-2f1e-11e4-8c21-0800200c9a66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0037-6824-10EPIFOAM1 in 1 CARTONAEROSOL, FOAM15
0037-6824-10EPIFOAM10 g in 1 CANISTERAEROSOL, FOAM105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6824-10GM - Gram0037-6824a3aec347-f143-4a17-930c-357aff6ff9f812014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PRAMOXINEACTIVE MOIETY068X84E056EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999REPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPANEINACTIVE INGREDIENTT75W9911L6EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKEPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0REPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-6824EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240310_b22b8b41-2f1e-11e4-8c21-0800200c9a66.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPIFOAMPRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATEViatris Specialty LLCb22b8b41-2f1e-11e4-8c21-0800200c9a662024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086457
application number: ANDA086457
ndc (product): 0037-6824

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904783epifoam 1 % / 1 % Topical FoamPSNb22b8b41-2f1e-11e4-8c21-0800200c9a665
904782hydrocortisone acetate 1 % / pramoxine HCl 1 % Topical FoamPSNb22b8b41-2f1e-11e4-8c21-0800200c9a665
904783hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Foam [Epifoam]SBDb22b8b41-2f1e-11e4-8c21-0800200c9a665
904782hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical FoamSCDb22b8b41-2f1e-11e4-8c21-0800200c9a665
904783Epifoam (hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % ) Topical FoamSYb22b8b41-2f1e-11e4-8c21-0800200c9a665
904782hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Topical FoamSYb22b8b41-2f1e-11e4-8c21-0800200c9a665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-6824-10000376824101 CANISTER in 1 CARTON (0037-6824-10) / 10 g in 1 CANISTER1 canister2014-08-250000-00-00NoNoCurrent