FDA.reportPublic FDA data

Plak Smacker GREAT WHITE SHARK

Product NDC
72326-8003
Requested package NDC
72326-8003-2
11-digit product format
723268003
Labeler code
72326
Product ID
72326-8003_42c89a4f-eb42-0a12-e063-6394a90a4ab0
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
YOUNG PS ACQUISITION, LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-27
Substance
SODIUM FLUORIDE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Plak Smacker GREAT WHITE SHARK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca5b91aa-f69c-4553-a2b6-acf0ca1d920eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
72326-8003-12023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-12023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-22023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-22023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-32023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-32023-10-18Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-12020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-12020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-22020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-22020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-32020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY
72326-8003-32020-01-31Plak Smacker GREAT WHITE SHARK ANTI-CAVITY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72326-8003-1Plak Smacker GREAT WHITE SHARK120 g in 1 TUBEPASTE1204
72326-8003-2Plak Smacker GREAT WHITE SHARK24 g in 1 TUBEPASTE244
72326-8003-3Plak Smacker GREAT WHITE SHARK24 g in 1 TUBEPASTE244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72326-8003PLAK SMACKER GREAT WHITE SHARK (SODIUM FLUORIDE) PASTE [YOUNG PS ACQUISITION, LLC]3Current NDC, Legacy NDC, 3 package rows20231122_ca5b91aa-f69c-4553-a2b6-acf0ca1d920e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNca5b91aa-f69c-4553-a2b6-acf0ca1d920e4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDca5b91aa-f69c-4553-a2b6-acf0ca1d920e4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYca5b91aa-f69c-4553-a2b6-acf0ca1d920e4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYca5b91aa-f69c-4553-a2b6-acf0ca1d920e4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYca5b91aa-f69c-4553-a2b6-acf0ca1d920e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72326-8003-27232680030224 g in 1 TUBE (72326-8003-2) 24 g2023-07-19NoNoCurrent