Hydrocortisone Acetate

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
Generic name: HYDROCORTISONE ACETATE
Manufacturer: Bryant Ranch Prepack
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 653fa10e-ab54-4b14-9ffa-8fd95b5e1040
SPL ID: b2fe39a6-f48e-46d9-ab00-d8865d7e06e9
Version: 103
Effective date: 2024-01-11
Source export date: 2026-11-06
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:12:54

Harmonized routes table
Harmonized routes
RECTAL

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Hydrocortisone Acetate	openfda.brand_name
generic name		HYDROCORTISONE ACETATE	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	63629-2530-1	openfda.package_ndc
ndc	product	63629-2530	openfda.product_ndc
ndc11	package	63629253001	derived:openfda.package_ndc
rxcui		1291082	openfda.rxcui
spl id		b2fe39a6-f48e-46d9-ab00-d8865d7e06e9	id
spl set id		653fa10e-ab54-4b14-9ffa-8fd95b5e1040	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 have been reported with corticosteroid suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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