Plak Smacker GREAT WHITE SHARK

Product NDC
72326-8003
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72326-8003-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72326-8003-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72326-8003-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72326-8003-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72326-8003-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72326-8003-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72326-8003-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72326-8003-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72326-8003-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72326-8003-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72326-8003-18dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72326-8003-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage72326-8003-3e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage72326-8003-1e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage72326-8003-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage72326-8003-39bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage72326-8003-19bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage72326-8003-29bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

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#

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 39 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2ba2318e-7a58-7b68-e063-6394a90ae7842025-03-13WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint Anticavity FluorideSODIUM FLUORIDEKenvue Brands LLCed15e0b9-00c9-0df1-e053-2a95a90a42c02025-02-28WarningsExact identifier
application number: M021
WHITE GLO BIO-ENZYMESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCf894a841-0df7-470d-8fc2-c9d6ba0edf992025-02-26WarningsExact identifier
application number: M021
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
application number: M021
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact 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
72326-8003-172326800301120 g in 1 TUBE (72326-8003-1) 120 g2023-07-19NoNoCurrent
72326-8003-27232680030224 g in 1 TUBE (72326-8003-2) 24 g2023-07-19NoNoCurrent
72326-8003-37232680030324 g in 1 TUBE (72326-8003-3) 24 g2023-07-19YesNoCurrent