Hismile

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: Hismile
Generic name: CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE
Manufacturer: HISMILE PTY LTD
Product type: HUMAN OTC DRUG
SPL set ID: 1e725b7e-accc-f51c-e063-6394a90a455c
SPL ID: 4879b95b-12f8-e9c9-e063-6294a90a9f28
Version: 2
Effective date: 2026-01-15
Source export date: 2026-10-27
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:41:18

Harmonized routes table
Harmonized routes
DENTAL

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		M021	openfda.application_number
brand name		Hismile	openfda.brand_name
generic name		CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	openfda.generic_name
manufacturer name		HISMILE PTY LTD	openfda.manufacturer_name
ndc	package	83013-327-06	openfda.package_ndc
ndc	product	83013-327	openfda.product_ndc
ndc11	package	83013032706	derived:openfda.package_ndc
rxcui		416783	openfda.rxcui
spl id		4879b95b-12f8-e9c9-e063-6294a90a9f28	id
spl set id		1e725b7e-accc-f51c-e063-6394a90a455c	set_id
unii		8ZYQ1474W7	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 Warnings When using this product Do not swallow Do not use in eye area Keep out of reach of children under 6 years of age If more than used for brushing is accidentally 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.