Thera Plus Eczema Hydrocortisone Anti Itch

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: Thera Plus Eczema Hydrocortisone Anti Itch
Generic name: HYDROCORTISONE
Manufacturer: Fourstar Group USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 7c72217b-db9a-4573-9f14-4c11528fa452
SPL ID: 2f86cd1f-b555-754f-e063-6394a90a5d94
Version: 2
Effective date: 2025-03-04
Source export date: 2026-10-27
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:49:21

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		Thera Plus Eczema Hydrocortisone Anti Itch	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Fourstar Group USA, Inc.	openfda.manufacturer_name
ndc	package	80684-146-00	openfda.package_ndc
ndc	product	80684-146	openfda.product_ndc
ndc11	package	80684014600	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		2f86cd1f-b555-754f-e063-6394a90a5d94	id
spl set id		7c72217b-db9a-4573-9f14-4c11528fa452	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 genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes. do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs 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.