PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE

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: PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE
Generic name: HYDROCORTISONE
Manufacturer: Click Industries LLC
Product type: HUMAN OTC DRUG
SPL set ID: 328c389c-7e05-4892-a9b3-b6a753f4935a
SPL ID: 170f47cc-f0ae-4ad1-b740-33cc53accb0f
Version: 1
Effective date: 2025-08-25
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:23

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Click Industries LLC	openfda.manufacturer_name
ndc	package	86173-005-16	openfda.package_ndc
ndc	package	86173-005-04	openfda.package_ndc
ndc	product	86173-005	openfda.product_ndc
ndc11	package	86173000504	derived:openfda.package_ndc
ndc11	package	86173000516	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		170f47cc-f0ae-4ad1-b740-33cc53accb0f	id
spl set id		328c389c-7e05-4892-a9b3-b6a753f4935a	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 • Rectal bleeding occurs • Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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