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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 72326-8003-3 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 72326-8003-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 72326-8003-2 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 72326-8003-3 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 72326-8003-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 72326-8003-2 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 72326-8003-3 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 72326-8003-1 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 72326-8003-2 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 72326-8003-3 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 72326-8003-1 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 72326-8003-2 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 72326-8003-3 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 72326-8003-1 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 72326-8003-2 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 72326-8003-3 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 72326-8003-1 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 72326-8003-2 | 9bebd1f3094a… | 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 |
|---|---|
| SODIUM FLUORIDE | 1.4 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416783 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 72326-8003-1 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-1 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-2 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-2 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-3 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-3 | 2023-10-18 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-1 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-1 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-2 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-2 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-3 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
| 72326-8003-3 | 2020-01-31 | Plak Smacker GREAT WHITE SHARK ANTI-CAVITY |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72326-8003-1 | Plak Smacker GREAT WHITE SHARK | 120 g in 1 TUBE | PASTE | 120 | 4 | |
| 72326-8003-2 | Plak Smacker GREAT WHITE SHARK | 24 g in 1 TUBE | PASTE | 24 | 4 | |
| 72326-8003-3 | Plak Smacker GREAT WHITE SHARK | 24 g in 1 TUBE | PASTE | 24 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72326-8003 | PLAK SMACKER GREAT WHITE SHARK (SODIUM FLUORIDE) PASTE [YOUNG PS ACQUISITION, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20231122_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dentalclean Green Diamond Alcohol Free Mouthwash | SODIUM FLUORIDE 0.05% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 5653aa33-4f0e-46b2-9be0-6219143556ec | 2025-07-14 | Warnings | M021 |
| Colgate Total Gum Protect Fresh Mint | STANNOUS FLUORIDE | COLGATE PALMOLIVE COMPANY | 570e3bd6-eede-4270-9d78-055aeb2b8c17 | 2025-07-14 | Warnings | M021 |
| OraPro Fluoride Anticavity | FLUORIDE TOOTHPASTE | Protegera, Inc. | 93b0181c-e29f-42f4-80f5-366463b68f09 | 2025-07-10 | Warnings | M021 |
| Enamur Fluoride AntiCavity Toothpast | FLUORIDE TOOTHPAST | Protegera, Inc | 557ced45-f54e-43d8-aa13-46f75b79367c | 2025-07-10 | Warnings | M021 |
| Super Strawberry | STRAWBERRY TOOTHPASTE | SuperMouth, LLC. | a8c2b68d-d28b-41c0-a383-cc706b25aa1a | 2025-07-05 | Warnings | M021 |
| Super Mint | SUPER MINT TOOTHPASTE | SuperMouth, LLC. | be0915f3-36c4-4200-9d15-704cfbd632b4 | 2025-07-05 | Warnings | M021 |
| Super Vanilla | VANILLA TOOTHPASTE | SuperMouth, LLC. | 3ddfe20a-86f1-4566-bb77-82c9749411f6 | 2025-07-05 | Warnings | M021 |
| Super Chocolate | CHOCOLATE TOOTHPASTE | SuperMouth, LLC. | 48607622-7c5e-4ddc-8d83-707f26c0553f | 2025-07-05 | Warnings | M021 |
| CURODONT REPAIR FLUORIDE PLUS | SODIUM FLUORIDE | CREDENTIS AG | 290c57b0-a562-0a51-e063-6294a90a0720 | 2025-06-23 | Warnings | M021 |
| KarlnHans Fresh Breath Jasmine Mint | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | 384863bd-b2cb-a46d-e063-6394a90a3ce2 | 2025-06-23 | Warnings | M021 |
| KarlnHans Fresh Breath Double Mint | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | 38487130-9508-a2c4-e063-6394a90aa323 | 2025-06-23 | Warnings | M021 |
| Crest Kids SparkleFun Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f0e81a-03bf-e17f-e063-6394a90a7358 | 2025-06-12 | Warnings | M021 |
| Freshen Up | SODIUM FLUORIDE, POTASSIUM NITRATE | MKJ BRANDS LLC | 2ee626d1-6150-87db-e063-6294a90a64d8 | 2025-06-12 | Warnings | M021 |
| Colgate MaxFresh Citrus Fresh | SODIUM FLUORIDE | Colgate-Palmolive Company | 13a74642-51d2-493c-ae97-a54508546a74 | 2025-06-12 | Warnings | M021 |
| Colgate MaxFresh Watermelon Blast | SODIUM FLUORIDE | Colgate-Palmolive Company | 4f07f945-6594-40f4-bc19-6acc12c37cdd | 2025-06-12 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 36994628-e5f3-3c35-e063-6294a90a609d | 2025-06-02 | Warnings | M021 |
| EUTHYMOL WHITENING SPECIAL GIFT SET | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 35bfa3fc-106e-aecc-e063-6294a90a7eb0 | 2025-05-22 | Warnings | M021 |
| EUTHYMOL WHITENING GIFT SET (40gX3) | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369aa02f-c312-6a0d-e063-6294a90adaa5 | 2025-05-22 | Warnings | M021 |
| EUTHYMOL WHITENING TRAVEL | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 3596306e-858c-9bf7-e063-6294a90ac1d6 | 2025-05-20 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 3582cc91-8c32-9f93-e063-6394a90a8792 | 2025-05-19 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | 4 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | 4 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | 4 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | 4 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | ca5b91aa-f69c-4553-a2b6-acf0ca1d920e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72326-8003-1 | 72326800301 | 120 g in 1 TUBE (72326-8003-1) | 120 g | 2023-07-19 | No | No | Current |
| 72326-8003-2 | 72326800302 | 24 g in 1 TUBE (72326-8003-2) | 24 g | 2023-07-19 | No | No | Current |
| 72326-8003-3 | 72326800303 | 24 g in 1 TUBE (72326-8003-3) | 24 g | 2023-07-19 | Yes | No | Current |