Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

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: Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Generic name: SODIUM FLUORIDE
Manufacturer: Yangzhou ONE & ONLY Personal Care Products Co., LTD
Product type: HUMAN OTC DRUG
SPL set ID: bb93fb1a-885a-4d2a-a1c2-3b37bc305d57
SPL ID: 2bce1352-ed26-a13d-e063-6394a90a2d08
Version: 1
Effective date: 2025-01-16
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:33:29

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 · 25 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Yangzhou ONE & ONLY Personal Care Products Co., LTD	openfda.manufacturer_name
ndc	package	85162-003-02	openfda.package_ndc
ndc	package	85162-003-07	openfda.package_ndc
ndc	package	85162-003-06	openfda.package_ndc
ndc	package	85162-003-05	openfda.package_ndc
ndc	package	85162-003-04	openfda.package_ndc
ndc	package	85162-003-08	openfda.package_ndc
ndc	package	85162-003-03	openfda.package_ndc
ndc	package	85162-003-01	openfda.package_ndc
ndc	product	85162-003	openfda.product_ndc
ndc11	package	85162000306	derived:openfda.package_ndc
ndc11	package	85162000303	derived:openfda.package_ndc
ndc11	package	85162000301	derived:openfda.package_ndc
ndc11	package	85162000302	derived:openfda.package_ndc
ndc11	package	85162000304	derived:openfda.package_ndc
ndc11	package	85162000307	derived:openfda.package_ndc
ndc11	package	85162000308	derived:openfda.package_ndc
ndc11	package	85162000305	derived:openfda.package_ndc
rxcui		416783	openfda.rxcui
spl id		2bce1352-ed26-a13d-e063-6394a90a2d08	id
spl set id		bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	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 Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately. Do not use if the inner foil is torn, cut, or missing Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.