Hydrocortisone Cream

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 Cream
Generic name: HYDROCORTISONE
Manufacturer: Trifecta Pharmaceuticals USA
Product type: HUMAN OTC DRUG
SPL set ID: 4c96ec41-841c-322b-e054-00144ff8d46c
SPL ID: 34a27d85-dac3-2169-e063-6294a90ae708
Version: 11
Effective date: 2025-05-08
Source export date: 2026-10-30
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:39:50

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Hydrocortisone Cream	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals USA	openfda.manufacturer_name
ndc	package	69396-028-44	openfda.package_ndc
ndc	package	69396-028-33	openfda.package_ndc
ndc	package	69396-028-02	openfda.package_ndc
ndc	package	69396-028-01	openfda.package_ndc
ndc	product	69396-028	openfda.product_ndc
ndc11	package	69396002802	derived:openfda.package_ndc
ndc11	package	69396002801	derived:openfda.package_ndc
ndc11	package	69396002833	derived:openfda.package_ndc
ndc11	package	69396002844	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		34a27d85-dac3-2169-e063-6294a90ae708	id
spl set id		4c96ec41-841c-322b-e054-00144ff8d46c	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 avoid contact with eyes do not put this product into the rectum by using fingers or any mechanical device or applicator For External Anal Itching Users: do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton as it contains important information

Reported adverse events (FAERS/openFDA)#

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