Calming Itch and Irritation

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: Calming Itch and Irritation
Generic name: COLLOIDAL OATMEAL
Manufacturer: Better Planet Brands LLC
Product type: HUMAN OTC DRUG
SPL set ID: 1dd7e712-56a4-86c0-e063-6294a90a75cd
SPL ID: 45132ba3-8160-c77a-e063-6294a90a0868
Version: 5
Effective date: 2025-12-03
Source export date: 2026-10-30
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/023bc8d8aae5addb7530087bbbdb169b3ccbf36764f15b8ca67db07e1e5aea8b/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:08:23

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Calming Itch and Irritation	openfda.brand_name
generic name		COLLOIDAL OATMEAL	openfda.generic_name
manufacturer name		Better Planet Brands LLC	openfda.manufacturer_name
ndc	package	54136-183-24	openfda.package_ndc
ndc	product	54136-183	openfda.product_ndc
ndc11	package	54136018324	derived:openfda.package_ndc
rxcui		1591951	openfda.rxcui
spl id		45132ba3-8160-c77a-e063-6294a90a0868	id
spl set id		1dd7e712-56a4-86c0-e063-6294a90a75cd	set_id
unii		8PI54V663Y	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 When using this product Do not get into eyes Stop use and ask doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days 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.