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: Bentlin Products LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4346351c-8e11-46ae-b428-98d17f55beb9
SPL ID: 1054b185-9c83-4935-a364-9b6ce657edbc
Version: 5
Effective date: 2023-10-30
Source export date: 2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:37

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Hydrocortisone Acetate	openfda.brand_name
generic name		HYDROCORTISONE ACETATE	openfda.generic_name
manufacturer name		Bentlin Products LLC	openfda.manufacturer_name
ndc	package	47832-205-15	openfda.package_ndc
ndc	package	47832-205-34	openfda.package_ndc
ndc	package	47832-205-05	openfda.package_ndc
ndc	product	47832-205	openfda.product_ndc
ndc11	package	47832020505	derived:openfda.package_ndc
ndc11	package	47832020515	derived:openfda.package_ndc
ndc11	package	47832020534	derived:openfda.package_ndc
rxcui		1043690	openfda.rxcui
spl id		1054b185-9c83-4935-a364-9b6ce657edbc	id
spl set id		4346351c-8e11-46ae-b428-98d17f55beb9	set_id
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 For external use only Do not use For the treatment of diaper rash On children under the age of 2 except under the supervision of a doctor When using this product Avoid contact with the eyes Do not begin use any other hydrocortisone product unless directed by a doctor Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children . If swallowed get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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