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: Calamine
Generic name: CALAMINE 8%, ZINC OXIDE 8%
Manufacturer: Farmacias De Similares TX LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4ecd0add-11c9-cf3b-e063-6394a90adff6
SPL ID: 4ecd0add-11ca-cf3b-e063-6394a90adff6
Version: 1
Effective date: 2026-04-06
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 05:26:08

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	openfda.brand_name
generic name		CALAMINE 8%, ZINC OXIDE 8%	openfda.generic_name
manufacturer name		Farmacias De Similares TX LLC	openfda.manufacturer_name
ndc	package	85786-703-06	openfda.package_ndc
ndc	product	85786-703	openfda.product_ndc
ndc11	package	85786070306	derived:openfda.package_ndc
rxcui		617954	openfda.rxcui
spl id		4ecd0add-11ca-cf3b-e063-6394a90adff6	id
spl set id		4ecd0add-11c9-cf3b-e063-6394a90adff6	set_id
unii		SOI2LOH54Z	openfda.unii
unii		1K09F3G675	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 When using this product ■ do not get into eyes Stop use and ask a 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. In case of overdose, 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.