Hydrocortisone Acetate Cream

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: Hydrocortisone Acetate Cream
Generic name: HYDROCORTISONE ACETATE CREAM
Manufacturer: Allegis Holdings LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3b008546-afa5-fe5a-e063-6394a90adb3b
SPL ID: 3b007d65-4f52-825f-e063-6294a90a71bb
Version: 1
Effective date: 2025-07-28
Source export date: 2026-10-30
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:27:38

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	040396	derived:openfda.application_number
application number		ANDA040396	openfda.application_number
brand name		Hydrocortisone Acetate Cream	openfda.brand_name
generic name		HYDROCORTISONE ACETATE CREAM	openfda.generic_name
manufacturer name		Allegis Holdings LLC	openfda.manufacturer_name
ndc	package	71297-241-01	openfda.package_ndc
ndc	product	71297-241	openfda.product_ndc
ndc11	package	71297024101	derived:openfda.package_ndc
spl id		3b007d65-4f52-825f-e063-6294a90a71bb	id
spl set id		3b008546-afa5-fe5a-e063-6394a90adb3b	set_id
unii		3X7931PO74	openfda.unii

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 The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressing. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions hypopigmentation, period dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Reported adverse events (FAERS/openFDA)#

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