Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
- Product NDC
- 85162-003
- 11-digit product format
- 851620003
- Labeler code
- 85162
- Product ID
- 85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM FLUORIDE
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Yangzhou ONE & ONLY Personal Care Products Co., LTD
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-16
- Substance
- SODIUM FLUORIDE
- Active strength
- .1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .1 g/100g |
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 |
|---|---|
| bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85162-003-01 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-003-01 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 1 | |
| 85162-003-02 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 24 in 1 BOX | PASTE, DENTIFRICE | 24 | 1 | |
| 85162-003-02 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 5 in 1 CARTON | PASTE, DENTIFRICE | 5 | 1 | |
| 85162-003-03 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 50 g in 1 TUBE | PASTE, DENTIFRICE | 50 | 1 | |
| 85162-003-03 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-003-04 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 100 g in 1 TUBE | PASTE, DENTIFRICE | 100 | 1 | |
| 85162-003-04 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 72 in 1 BOX | PASTE, DENTIFRICE | 72 | 1 | |
| 85162-003-05 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 100 g in 1 TUBE | PASTE, DENTIFRICE | 100 | 1 | |
| 85162-003-05 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-003-06 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 28 g in 1 TUBE | PASTE, DENTIFRICE | 28 | 1 | |
| 85162-003-06 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 480 in 1 BOX | PASTE, DENTIFRICE | 480 | 1 | |
| 85162-003-07 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 72 in 1 BOX | PASTE, DENTIFRICE | 72 | 1 | |
| 85162-003-07 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 120 g in 1 TUBE | PASTE, DENTIFRICE | 120 | 1 | |
| 85162-003-08 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 120 g in 1 TUBE | PASTE, DENTIFRICE | 120 | 1 | |
| 85162-003-08 | Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85162-003 | PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD] | 1 | Current NDC, 16 package rows | 20250117_bb93fb1a-885a-4d2a-a1c2-3b37bc305d57.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 |
|---|---|---|---|---|---|---|
| COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT | SODIUM FLUORIDE | Colgate-Palmolive Company | b1ef8277-9919-453c-9d21-da4666d952de | 2026-09-17 | Warnings | M021 |
| TheraBreath | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 53c1086d-264b-9d00-e063-6394a90ad19d | 2026-09-09 | Warnings | M021 |
| Opalescence Whitening Cool Mint | SODIUM FLUORIDE | Ultradent Products, Inc. | 44e7d0ed-3c37-5889-e063-6294a90afcca | 2026-09-09 | Warnings | M021 |
| Opalescence Whitening | SODIUM FLUORIDE | Ultradent Products, Inc | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 2026-09-09 | Warnings | M021 |
| Opal by Opalescence Original | SODIUM FLUORIDE | Ultradent Products, Inc. | 5c3bf8fc-2e8f-4a58-bcbf-e47540072a49 | 2026-09-09 | Warnings | M021 |
| Opal by Opalescence Complete | OPAL BY OPALESCENCE COMPLETE | Ultradent Products, Inc. | 249cc46a-dad6-0345-e063-6394a90a4447 | 2026-09-09 | Warnings | M021 |
| Colgate MaxFresh Knockout | SODIUM FLUORIDE | Colgate-Palmolive Company | 0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9 | 2026-09-09 | Warnings | M021 |
| Colgate MaxFresh Charcoal | SODIUM FLUORIDE | Colgate-Palmolive Company | de3674f4-3ce6-47d5-8391-6ad6789d68d9 | 2026-09-09 | Warnings | M021 |
| Freshmint Premium Anticavity | SODIUM FLUORIDE | New World Imports, Inc | ef108fff-a79c-4e8d-8bf0-3fe567f93eb8 | 2026-09-08 | Warnings | M021 |
| Freshmint Premium Anticavity | SODIUM FLUORIDE | New World Imports, Inc | 1a42cf2d-6c48-4e38-97bc-b6f2084bf39b | 2026-09-08 | Warnings | M021 |
| Freshmint Premium Anticavity Gel | SODIUM FLUORIDE | New World Imports, Inc | dfe564c1-2097-431d-93f0-cf423f254248 | 2026-09-08 | Warnings | M021 |
| Freshmint Anticavity Fluoride | SODIUM MONOFLUOROPHOSPHATE | New World Imports, Inc | 5aff7e41-58cd-5ab8-e063-6294a90aa1c7 | 2026-09-08 | Warnings | M021 |
| Colgate Optic White Advanced Sparkling White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | bc56603d-4190-48c1-b16e-3179a650cb39 | 2026-09-06 | Warnings | M021 |
| Dentalclean Advanced Pro | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 4d261dc8-b065-567f-e063-6294a90aa93f | 2026-09-04 | Warnings | M021 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA Attitude | 54bd43c9-489d-4e6b-9031-90ec0e3c4516 | 2026-09-01 | Warnings | M021 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA Attitude | 53c344e9-49f5-48aa-8309-1e15f80b80a0 | 2026-09-01 | Warnings | M021 |
| Unpaste | ZERO WASTE FLUORIDE MINT TOOTH TABS | Avespan LLC | 312ae88d-7ea4-b3e0-e063-6294a90a99e5 | 2026-09-01 | Warnings | M021 |
| Dentalclean Regenerator Sensitive Dental Gel with Fluoride | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 176aa3ed-e2a4-536d-e063-6294a90aa097 | 2026-08-31 | Warnings | M021 |
| Listerine Total Care Fresh Mint Anticavity | SODIUM FLUORIDE | Kenvue Brands LLC | b2ce66c3-dc48-47a5-a731-5550bc194679 | 2026-08-28 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Your Military Exchanges | cef74e9c-d3b5-4e92-9908-187be97b63ab | 2026-08-28 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 1 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85162-003-01 | 85162000301 | 144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-003-02 | 85162000302 | 5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE | 5 box | 2025-01-16 | No | No | Current |
| 85162-003-03 | 85162000303 | 144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-003-04 | 85162000304 | 72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE | 72 tube | 2025-01-16 | No | No | Current |
| 85162-003-05 | 85162000305 | 144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-003-06 | 85162000306 | 480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE | 480 tube | 2025-01-16 | No | No | Current |
| 85162-003-07 | 85162000307 | 72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE | 72 tube | 2025-01-16 | No | No | Current |
| 85162-003-08 | 85162000308 | 144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |