CAREALL Hydrocortisone Maximum Strength

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: CAREALL Hydrocortisone Maximum Strength
Generic name: HYDROCORTISONE
Manufacturer: New World Imports, Inc
Product type: HUMAN OTC DRUG
SPL set ID: d04e473d-8bbc-475c-a0b1-ca5eed67fbc7
SPL ID: 44ebbcfd-55da-4721-e063-6294a90aa70f
Version: 3
Effective date: 2025-12-01
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:35

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		CAREALL Hydrocortisone Maximum Strength	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		New World Imports, Inc	openfda.manufacturer_name
ndc	package	51824-097-01	openfda.package_ndc
ndc	product	51824-097	openfda.product_ndc
ndc11	package	51824009701	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		44ebbcfd-55da-4721-e063-6294a90aa70f	id
spl set id		d04e473d-8bbc-475c-a0b1-ca5eed67fbc7	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: For the treatment of diaper rash. Consult a doctor if you have vaginal discharge. Consult a doctor When using this product: Avoid contact with the eyes Do not use more than directed unless told to do so by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator If rectal bleeding occurs, consult a doctor promptly Stop use and ask a doctor if: Condition worsens, symptoms persist 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.

Reported adverse events (FAERS/openFDA)#

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