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: SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE
Manufacturer: Hismile Pty Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 0ef41051-dfa0-b105-e063-6294a90a551f
SPL ID: 4878b60a-cd0f-5156-e063-6394a90a59ee
Version: 4
Effective date: 2026-01-15
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 05:27:24

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		SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	openfda.generic_name
manufacturer name		Hismile Pty Ltd	openfda.manufacturer_name
ndc	package	83013-314-06	openfda.package_ndc
ndc	product	83013-314	openfda.product_ndc
ndc11	package	83013031406	derived:openfda.package_ndc
rxcui		416783	openfda.rxcui
spl id		4878b60a-cd0f-5156-e063-6394a90a59ee	id
spl set id		0ef41051-dfa0-b105-e063-6294a90a551f	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 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.