FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui904782, 904783

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

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