FDA.reportPublic FDA data

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#

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 42 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact identifier
application number: M021
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact 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