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 Pro Health Advanced Enamel Restore | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d813f5f0-3135-4a8f-e053-2a95a90a5562 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8e189fbd-5094-4398-b96c-8f95d89b9cdd | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Densify Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d84fb9f9-f2bc-358a-e053-2995a90abf07 | 2026-01-08 | Warnings | M021 |
| Kids Crest Strawberry Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | eb7a5698-754c-4e46-e053-2a95a90a57b4 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Daily Cleansing and Whitening System | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 89a6fb36-5109-47f1-95ad-9381471ceeef | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced w/Extra Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 2c1c5563-0b7e-4c7c-b49f-3d72e078cd28 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Fresh Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c81ba39d-c7ea-b2a5-e053-2995a90a0fe7 | 2026-01-08 | M021 | |
| Crest Premium Plus Breath Bacteria Blast | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c3f1d477-6dd8-0ac4-e053-2a95a90a3742 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Active Foam Whitening scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c72b15e0-e69c-65fc-e053-2a95a90a54c8 | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus Scope Outlast Ultra | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c3f63455-b09e-9877-e053-2a95a90a1844 | 2026-01-08 | Warnings | M021 |
| Crest Tartar Protection Fresh Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d81d605-4f9b-3bb5-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Complete plus Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | e3b1f139-4fe8-f005-e053-2995a90a53b4 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f3dd7a34-a0d8-4ac6-bbd1-7c3b86187a57 | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus Active Fresh plus Whitening Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c599d33f-788f-7fdd-e053-2a95a90a5f57 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi Benefit Whitening plus Scope Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 66c41b24-d394-6609-e053-2a91aa0a0a2c | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus 3 in 1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b6fab2eb-da5c-749f-e053-2995a90a1357 | 2026-01-08 | Warnings | M021 |
| Crest Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 85477763-1db5-482f-90e5-e71f5c1b4765 | 2026-01-08 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f9b31f6b-6b3f-abe0-e053-6294a90acb25 | 2026-01-08 | Warnings | M021 |
| Crest Complete plus Whitening Deep Clean | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c367c2cc-5e0f-bc4e-e053-2995a90a2e2c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Glamorous White | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c3f29f95-81b9-3989-e053-2a95a90af3a6 | 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 |