CliniCalm

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: CliniCalm
Generic name: HYDROCORTISONE
Manufacturer: CP Skin Health Group, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: febcf7e8-668c-a5c9-e053-6394a90aec39
SPL ID: 2865dbce-02f6-ebe7-e063-6294a90ab3cb
Version: 6
Effective date: 2024-12-03
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:13:04

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		M006	openfda.application_number
brand name		CliniCalm	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		CP Skin Health Group, Inc.	openfda.manufacturer_name
ndc	package	68726-504-01	openfda.package_ndc
ndc	package	68726-504-02	openfda.package_ndc
ndc	product	68726-504	openfda.product_ndc
ndc11	package	68726050402	derived:openfda.package_ndc
ndc11	package	68726050401	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		2865dbce-02f6-ebe7-e063-6294a90ab3cb	id
spl set id		febcf7e8-668c-a5c9-e053-6394a90aec39	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 the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician. Do not use for the treatment of diaper rash. Consult a physician. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If product is 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.