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 |
|---|---|---|---|---|---|---|
| Crest Clean Breath Peppermint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ef07b-ee68-e6ae-e063-6394a90af5e5 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f20343e-6c03-48e8-e063-6294a90a8cdf | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Smooth Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f2042b4-8eae-5c2c-e063-6394a90a640c | 2026-04-10 | Warnings | M021 |
| Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4146d-6281-fe66-e063-6394a90a32c3 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef5261e-9d2f-ae05-e063-6294a90a489a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0876d9-41c9-d891-e063-6394a90a1cbd | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Charcoal with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef57a05-b9f5-42f7-e063-6294a90a5d89 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ee26a82-16fd-f0fb-e063-6394a90a91d1 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Whitening Therapy Deep Clean Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 812c1519-1a4b-2495-e053-2a91aa0a914a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4e7c2-1f58-59fc-e063-6294a90ad43b | 2026-04-08 | Warnings | M021 |
| Anticavity mouth rinse Low-foaming Spearmint | 779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT | Dyson Technology Limited | 4ef669b9-defe-8965-e063-6394a90ab335 | 2026-04-08 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c89efc-5fa0-2a05-e053-2a95a90a7b9c | 2026-04-07 | Warnings | M021 |
| Crest 3D White Advanced Charcoal | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f4eb8111-53da-17ae-e053-2a95a90a1127 | 2026-04-07 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | 35385ada-bd8d-4d38-9587-0256885f749f | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | cf0c8b48-0d1c-406a-a67d-7d16187d38d8 | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Crest 3D White Arctic Fresh | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fa08a877-b9e5-4eba-b832-3a28f4f3f83c | 2026-04-07 | Warnings | M021 |
| Anticavity Fluoride | SODIUM FLUORIDE | Family Dollar (FAMILY WELLNESS) | 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46 | 2026-04-01 | Warnings | M021 |
| CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796 | 2026-04-01 | Warnings | M021 |
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 5f87abb7-0e9d-6369-e053-2a91aa0a2411 | 2026-03-31 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4e544d09-0cf3-f0c7-e063-6394a90a2369 | 2026-03-31 | Warnings | 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 |