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: Proficient Rx LP
Product type: HUMAN OTC DRUG
SPL set ID: c57d5f8e-5934-4cbb-999a-cdd55e5b105f
SPL ID: da956cb1-6755-4155-a49c-3173cb7423cf
Version: 4
Effective date: 2024-02-01
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 07:12:29

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		Proficient Rx LP	openfda.manufacturer_name
ndc	package	63187-543-01	openfda.package_ndc
ndc	product	63187-543	openfda.product_ndc
ndc11	package	63187054301	derived:openfda.package_ndc
rxcui		203105	openfda.rxcui
spl id		da956cb1-6755-4155-a49c-3173cb7423cf	id
spl set id		c57d5f8e-5934-4cbb-999a-cdd55e5b105f	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 • in the eyes • by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have • a vaginal discharge • rectal bleeding • diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if • condition gets worse • condition persists for more than 7 days • condition clears up and occurs again within a few days. Do not begin to use 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.

Reported adverse events (FAERS/openFDA)#

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