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: BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE
Manufacturer: Hismile Pty Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 0ef7be5b-df8f-9f32-e063-6394a90a4724
SPL ID: 4878ea23-43ad-8751-e063-6394a90ac32f
Version: 3
Effective date: 2026-01-15
Source export date: 2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:30:31

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		BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	openfda.generic_name
manufacturer name		Hismile Pty Ltd	openfda.manufacturer_name
ndc	package	83013-319-06	openfda.package_ndc
ndc	product	83013-319	openfda.product_ndc
ndc11	package	83013031906	derived:openfda.package_ndc
rxcui		416783	openfda.rxcui
spl id		4878ea23-43ad-8751-e063-6394a90ac32f	id
spl set id		0ef7be5b-df8f-9f32-e063-6394a90a4724	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.