Sunmark Phenolated Calamine

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: Sunmark Phenolated Calamine
Generic name: CALAMINE AND ZINC OXIDE AND PHENOL
Manufacturer: Strategic Sourcing Services LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8e68efc4-4c95-41c0-9fed-32297b1b2edc
SPL ID: 0ce5c95c-a899-9b32-e063-6294a90a86b9
Version: 6
Effective date: 2023-12-19
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:20:03

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		Sunmark Phenolated Calamine	openfda.brand_name
generic name		CALAMINE AND ZINC OXIDE AND PHENOL	openfda.generic_name
manufacturer name		Strategic Sourcing Services LLC	openfda.manufacturer_name
ndc	package	49348-802-34	openfda.package_ndc
ndc	product	49348-802	openfda.product_ndc
ndc11	package	49348080234	derived:openfda.package_ndc
rxcui		991369	openfda.rxcui
spl id		0ce5c95c-a899-9b32-e063-6294a90a86b9	id
spl set id		8e68efc4-4c95-41c0-9fed-32297b1b2edc	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.