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: Cosette Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: c84ab549-1d5c-4646-a041-6cb571812ad8
SPL ID: 0acd8136-06dc-4ea4-e063-6394a90a5b51
Version: 2
Effective date: 2023-11-23
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:12:25

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		Cosette Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0713-0493-12	openfda.package_ndc
ndc	product	0713-0493	openfda.product_ndc
ndc11	package	00713049312	derived:openfda.package_ndc
rxcui		1291085	openfda.rxcui
spl id		0acd8136-06dc-4ea4-e063-6394a90a5b51	id
spl set id		c84ab549-1d5c-4646-a041-6cb571812ad8	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 Hydrocortisone Acetate Suppositories: 1. Burning 5. Folliculitis 2. Itching 6. Hypopigmentation 3. Irritation 7. Allergic Contact Dermatitis 4. Dryness 8. Secondary Infection To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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.