HYDROCORTISONE

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
Generic name: HYDROCORTISONE
Manufacturer: CVS PHARMACY, INC
Product type: HUMAN OTC DRUG
SPL set ID: 8b8cdb26-8e8f-4e95-9d83-d685c90afe01
SPL ID: 49d96221-1455-d749-e063-6394a90a443e
Version: 4
Effective date: 2026-02-02
Source export date: 2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:53:14

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 number		M017	openfda.application_number
brand name		HYDROCORTISONE	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		CVS PHARMACY, INC	openfda.manufacturer_name
ndc	package	51316-230-00	openfda.package_ndc
ndc	product	51316-230	openfda.product_ndc
ndc11	package	51316023000	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		49d96221-1455-d749-e063-6394a90a443e	id
spl set id		8b8cdb26-8e8f-4e95-9d83-d685c90afe01	set_id
unii		WI4X0X7BPJ	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. Consult a doctor. When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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