AMERFRESH FLUORIDE
- Product NDC
- 85162-002
- 11-digit product format
- 851620002
- Labeler code
- 85162
- Product ID
- 85162-002_2bce0fcd-1d50-cf52-e063-6394a90a3603
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- TOPICAL
- 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
- AMERFRESH FLUORIDE
- 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 |
|---|---|
| 245598 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85162-002-01 | AMERFRESH FLUORIDE | 17 g in 1 TUBE | PASTE, DENTIFRICE | 17 | 1 | |
| 85162-002-01 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-02 | AMERFRESH FLUORIDE | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 1 | |
| 85162-002-02 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-03 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-03 | AMERFRESH FLUORIDE | 43 g in 1 TUBE | PASTE, DENTIFRICE | 43 | 1 | |
| 85162-002-04 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-04 | AMERFRESH FLUORIDE | 78 g in 1 TUBE | PASTE, DENTIFRICE | 78 | 1 | |
| 85162-002-05 | AMERFRESH FLUORIDE | 85 g in 1 TUBE | PASTE, DENTIFRICE | 85 | 1 | |
| 85162-002-05 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-06 | AMERFRESH FLUORIDE | 142 g in 1 TUBE | PASTE, DENTIFRICE | 142 | 1 | |
| 85162-002-06 | AMERFRESH FLUORIDE | 144 in 1 BOX | PASTE, DENTIFRICE | 144 | 1 | |
| 85162-002-07 | AMERFRESH FLUORIDE | 7 g in 1 POUCH | PASTE, DENTIFRICE | 7 | 1 | |
| 85162-002-07 | AMERFRESH FLUORIDE | 1000 in 1 BOX | PASTE, DENTIFRICE | 1000 | 1 |
DailyMed Dashboard NDC Coverage#
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 Sensitive and Enamel Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb48b15c-f821-e5cd-e053-6294a90ac64c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Luminous Purple | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fbfcd837-4d88-5f82-e053-6394a90afbf6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health with a Touch of Scope | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb572b41-36cd-55d7-e053-6394a90a71c8 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Whitening Gel | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb5b1e94-bed6-8486-e053-6294a90a3a84 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Ultra Vivid Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | cba96ef0-0519-059f-e053-2a95a90a43ad | 2026-01-08 | Warnings | M021 |
| Crest 4in1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ce545406-3c4f-1ba7-e053-2a95a90a91ac | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d218ddc0-1d5f-f39b-e053-2995a90a96ed | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Antibacterial Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d58bc842-2687-e52d-e053-2995a90a5433 | 2026-01-08 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d65b3153-2026-a8c0-e053-2a95a90a31d6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Charcoal | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6f68485-b92f-41c7-e053-2995a90a4fe5 | 2026-01-08 | Warnings | M021 |
| KIDS Crest Advanced Enamel Plus Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d837ecde-249a-7868-e053-2a95a90a56ae | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Intensive Cleaning | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6fa4187-a651-647b-e053-2995a90a8567 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Gum Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7729dde-c828-34e6-e053-2a95a90a5ee6 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d811306f-4994-7a5a-e053-2995a90adf16 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d810d4e5-ba66-efe1-e053-2995a90abfc0 | 2026-01-08 | Warnings | M021 |
| Crest Braces Care Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d823cba4-c4cf-7d7a-e053-2995a90a01f0 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Sensitive Relief | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7730674-7513-52cf-e053-2995a90ab32c | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Flavor | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 26a7a892-5da4-4749-bbb6-566efab7d749 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi-Benefit Plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8c91095d-88c0-4d22-a79a-7d0f0d05302b | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Deep Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d774295f-8ebd-9877-e053-2a95a90a9a0e | 2026-01-08 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245598 | sodium fluoride 0.22 % Toothpaste | PSN | 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 | 1 |
| 245598 | sodium fluoride 0.0022 MG/MG Toothpaste | SCD | 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 | 1 |
| 245598 | sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste | SY | 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85162-002-01 | 85162000201 | 144 TUBE in 1 BOX (85162-002-01) / 17 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-02 | 85162000202 | 144 TUBE in 1 BOX (85162-002-02) / 24 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-03 | 85162000203 | 144 TUBE in 1 BOX (85162-002-03) / 43 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-04 | 85162000204 | 144 TUBE in 1 BOX (85162-002-04) / 78 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-05 | 85162000205 | 144 TUBE in 1 BOX (85162-002-05) / 85 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-06 | 85162000206 | 144 TUBE in 1 BOX (85162-002-06) / 142 g in 1 TUBE | 144 tube | 2025-01-16 | No | No | Current |
| 85162-002-07 | 85162000207 | 1000 POUCH in 1 BOX (85162-002-07) / 7 g in 1 POUCH | 1000 pouch | 2025-01-16 | No | No | Current |