Thera plus Anti-itch with aloe 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: Thera plus Anti-itch with aloe Hydrocortisone
Generic name: HYDROCORTISONE
Manufacturer: Fourstar Group USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c69d0670-a65b-1680-e053-2995a90a2ee5
SPL ID: 08a0f5fb-bc99-45d2-e063-6294a90a623c
Version: 2
Effective date: 2023-10-26
Source export date: 2026-10-27
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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:46:39

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 Anti-itch with aloe Hydrocortisone	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Fourstar Group USA, Inc.	openfda.manufacturer_name
ndc	package	80684-038-01	openfda.package_ndc
ndc	product	80684-038	openfda.product_ndc
ndc11	package	80684003801	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		08a0f5fb-bc99-45d2-e063-6294a90a623c	id
spl set id		c69d0670-a65b-1680-e053-2995a90a2ee5	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 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.

Reported adverse events (FAERS/openFDA)#

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