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 plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c5d5bc17-e81b-34aa-e053-2a95a90ad77f | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c5745cc4-213d-1dde-e053-2995a90af562 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960fef18-4533-5250-e053-2995a90aaf76 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c574b51d-07bd-b363-e053-2995a90a7c0e | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Blast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6d9a1754-8d38-054f-e053-2991aa0a4653 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Breath Purify and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c60fdacf-d997-19a5-e053-2a95a90a96a3 | 2026-01-08 | Warnings | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d7fffb9-47e0-73cd-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Ultra | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c73ed36a-0e2f-a137-e053-2a95a90a43e0 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Extra Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c688d37e-9e80-4599-e053-2a95a90a1916 | 2026-01-08 | Warnings | M021 |
| Crest Gum Detoxify plus Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 63779942-0f6c-11c5-e053-2991aa0a25ab | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Sensitivity Active Foam | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | b8535d1c-cf15-f353-e053-2a95a90a7974 | 2026-01-08 | Warnings | M021 |
| Burts Bees Extra White Zen Peppermint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 81279e1f-6224-8114-e053-2991aa0aab08 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Bacteria Shield and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c74229c4-b095-df32-e053-2a95a90a4aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | c8350ab3-9347-58c0-e053-2995a90a7238 | 2026-01-08 | M021 | |
| Crest Premium Plus Anti-Bacterial | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | b7af946e-1cac-b8c0-e053-2a95a90afa4a | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Polishing Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ddcb0871-9900-125f-e053-2a95a90a75de | 2026-01-08 | M021 | |
| Burts Bees Deep Clean plus Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c924b8dd-8d84-1329-e053-2995a90a4531 | 2026-01-08 | Warnings | M021 |
| Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 07ed767e-225c-e9c5-e063-6394a90af931 | 2026-01-08 | Warnings | M021 |
| Crest Plus Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 0813171e-bda5-b004-e063-6394a90ad364 | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 087b3434-2636-74ce-e063-6394a90a25ad | 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 |