Calamine Phenolated Topical Suspension

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: Calamine Phenolated Topical Suspension
Generic name: CALAMINE AND ZINC OXIDE AND PHENOL
Manufacturer: Humco Holding Group, Inc
Product type: HUMAN OTC DRUG
SPL set ID: a3816729-be2b-4b4f-a609-953576cd2e3b
SPL ID: 0c92d58b-b1c7-dc2c-e063-6394a90a4d7a
Version: 6
Effective date: 2023-12-15
Source export date: 2026-10-30
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/7f38ccf216257b076837276c278194f298b4ccda641215a8f83814b33a860b51/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 20:01:20

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Calamine Phenolated Topical Suspension	openfda.brand_name
generic name		CALAMINE AND ZINC OXIDE AND PHENOL	openfda.generic_name
manufacturer name		Humco Holding Group, Inc	openfda.manufacturer_name
ndc	package	0395-0407-96	openfda.package_ndc
ndc	product	0395-0407	openfda.product_ndc
ndc11	package	00395040796	derived:openfda.package_ndc
rxcui		991369	openfda.rxcui
spl id		0c92d58b-b1c7-dc2c-e063-6394a90a4d7a	id
spl set id		a3816729-be2b-4b4f-a609-953576cd2e3b	set_id
unii		339NCG44TV	openfda.unii
unii		SOI2LOH54Z	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 . Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas. If applied to fingers or toes do not bandage.

Reported adverse events (FAERS/openFDA)#

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