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 Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960e0e3e-10e8-7426-e053-2a95a90a5b02 | 2026-02-12 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e | 2026-02-12 | Warnings | M021 |
| Kids Crest Cavity Protection Sparkle Fun | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 126c6f39-0ef7-40ee-b3ba-e56a76739c57 | 2026-02-12 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | CVS Pharmacy, Inc. | b2f7490c-e2af-49df-b054-70fb4815f729 | 2026-02-11 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | b7d7c41e-f8b6-4e55-8acd-78eb6dda47c5 | 2026-02-09 | Warnings | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | 48ef2635-7157-4cd7-9f99-967f0143f7f1 | 2026-02-09 | Warnings | M021 |
| Made by Dentists For Kids Eyeball Juice (Watermelon) | SODIUM FLUORIDE | MADE BY DENTISTS INC | 287887df-64de-4b5d-80e2-146c77c0fa8b | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES White Care AO Pro | SODIUM FLUORIDE | PERIOSCIENCES LLC | 092bdfa3-6267-439e-9320-e51b4805d1a1 | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES HYDRATING AO Pro | SODIUM MONOFLUOROPHOSPHATE | PERIOSCIENCES LLC | 5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3 | 2026-02-09 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | 77c066cf-f064-45d3-9732-4433165ba9ef | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | d1c878a9-2151-4986-be09-cbab658cdd31 | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 542e067a-c134-44c9-b962-f2a2b667b76f | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Colgate 5g Toothbrush Kit | SODIUM MONOFLUOROPHOSPHATE | Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd. | 4f0fda5e-ef42-42c3-8270-3ba614650ad1 | 2026-02-06 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 3954edfd-f7f1-4218-9ee2-23f5b3661b4e | 2026-02-06 | Warnings, Adverse reactions | M021 |
| TheraBreath Kids Anticavity Oral Rinse Bubblegum | ANTICAVITY ORAL RINSE | Church & Dwight Co., Inc. | 2770424d-7416-66d4-e063-6394a90ad4b1 | 2026-02-06 | Warnings | M021 |
| Crest Pro-Health Sensitivity Whitening Plus Scope | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 463b7820-a5ce-f8b5-e063-6394a90aa018 | 2026-02-05 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Publix Super Markets, Inc. | 14494238-872b-49e2-8bf7-df3844a0a6c8 | 2026-02-05 | Warnings, Adverse reactions | M021 |
| HAPEE EXPLOSIVE MENTHOL RED 150 | SODIUM MONOFLUOROPHOSPHATE | LAMOIYAN CORPORATION | 14c14694-6149-40a8-aff2-660d39f7e0c1 | 2026-02-05 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | HARRIS TEETER | f759e9e4-6de2-4b80-903b-e67c06e36295 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | HARRIS TEETER | 571f7628-fd59-462f-96dd-67aeaa98cff1 | 2026-02-04 | 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 |