EPIFOAM

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: EPIFOAM
Generic name: PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE
Manufacturer: Viatris Specialty LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: b22b8b41-2f1e-11e4-8c21-0800200c9a66
SPL ID: c99db232-5398-45ed-a621-83448f51f5ae
Version: 5
Effective date: 2024-02-15
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:28:08

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	086457	derived:openfda.application_number
application number		ANDA086457	openfda.application_number
brand name		EPIFOAM	openfda.brand_name
generic name		PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE	openfda.generic_name
manufacturer name		Viatris Specialty LLC	openfda.manufacturer_name
ndc	package	0037-6824-10	openfda.package_ndc
ndc	product	0037-6824	openfda.product_ndc
ndc11	package	00037682410	derived:openfda.package_ndc
rxcui		904782	openfda.rxcui
rxcui		904783	openfda.rxcui
spl id		c99db232-5398-45ed-a621-83448f51f5ae	id
spl set id		b22b8b41-2f1e-11e4-8c21-0800200c9a66	set_id
unii		88AYB867L5	openfda.unii
unii		3X7931PO74	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.