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 complete plus Whitening Deep Clean | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 973ce138-c64e-c059-e053-2a95a90a3148 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Gum Detoxify and Restore Pro Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4c3ad36-72d8-16e8-e053-2a95a90a8702 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Gum Detoxify and Restore Pro Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4d65b58-9818-820d-e053-2995a90a9f00 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Sensitive and Gum All Day Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Enamel Repair and Gum Advanced Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4ead762-17b2-22a0-e053-2a95a90ac866 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c82742-fb27-62a2-e053-2a95a90aa7c4 | 2026-01-08 | Warnings | M021 |
| Native Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | a5248d35-f488-3457-e053-2995a90a411e | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | b7882679-339c-554f-e053-2995a90afa7f | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | b6c180ae-00da-6fab-e053-2a95a90a089e | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus Scope Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b6f9a813-7ed6-895c-e053-2995a90a9ea6 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Scope Dual Blast Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b788d16a-8a58-0352-e053-2a95a90a965e | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Scope Outlast Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b789587e-7f49-163a-e053-2a95a90a823f | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Advanced Whitening Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b81a22dc-b759-24cd-e053-2995a90a9148 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Deep Clean Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b851fe5c-d904-12da-e053-2a95a90a86f9 | 2026-01-08 | Warnings | M021 |
| Crest Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | adebbd47-011d-4cd3-a002-1eb67e885e5b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c9b5ef-8dd4-a842-e053-2a95a90ad387 | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7baa77f5-fe45-6566-e053-2991aa0a381f | 2026-01-08 | Warnings | M021 |
| Crest 3D White Vibrant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f63c3354-a264-8130-e053-2a95a90a2022 | 2026-01-08 | M021 | |
| Crest Pro Health Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb466fb4-0915-a41f-e053-6294a90a2dfb | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Clean and Free | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb4771cd-f478-e2bd-e053-6394a90aa83e | 2026-01-08 | 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 |