Over-the-counter drug · OTC MONOGRAPH DRUG
AMERFRESH FLUORIDE gel (sodium fluoride) NDC 85162-001
Sodium fluoride .1 g/100g · Paste, Dentifrice · Topical · Yangzhou ONE & ONLY Personal Care Products Co., LTD
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85162-001-01 | 85162000101 | 144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-02 | 85162000102 | 144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-03 | 85162000103 | 144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-04 | 85162000104 | 144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-05 | 85162000105 | 144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-06 | 85162000106 | 144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBEMarketed from Jan 16, 2025 | |
| 85162-001-07 | 85162000107 | 1000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCHMarketed from Jan 16, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- AMERFRESH FLUORIDE gel
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .1 g/100g
- Dosage form
- Paste, Dentifrice
- Route
- Topical
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 85162-001_2bce0b25-f314-443b-e063-6394a90a4102SPL ID 2bce0b25-f314-443b-e063-6394a90a4102SPL set ID 86279b4d-82e5-45b5-9ba7-94fe3620b850RxCUI 245598UNII 8ZYQ1474W7
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485162000101followed by a unit qualifier and the quantityPackage 85162-0001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Aids in the prevention of dental cavities.
Excerpt only. Read the full label for complete information.
Other NDCs under M 021
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Therabreath Whiteningsodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-272 |
| evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluoride | Sodium fluoride .24 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-204 |
| Dentissesodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental, Oral | Dentisse, Inc. | 70683-0703 |
| ZONSEN Toothpaste,whitetoothpaste | Sodium fluoride .22 g/100g | Paste, DentifriceDental | Wuhan Zonsen Medical Products Co., Ltd. | 72932-016 |
| Brush Buddies Crayola Anticavity Fluoride Strawberrysodium fluoride | Sodium fluoride .02 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD | 73928-042 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-631 |
| Dr Tichenors With Extra Whitening and Tartar Controlsodium fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceOral | Dr. G. H. Tichenor's Antiseptic Company | 11291-243 |
| Hello Whipped Mellow Mint Dream Flavorsodium monofluorophosphate | Sodium monofluorophosphate 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-513 |
| Glowing Whitesodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Demoulas Super Markets, Inc | 53942-435 |
| Crest Premium Plus Breath Bacteria Blaststannous fluoride | Stannous fluoride 1.4 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-912 |
| Brush Buddies Brbie Anticavity Fluoride Bubblegumsodium fluoride | Sodium fluoride .05 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD. | 73928-039 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-632 |
| Orajel Kids Supermananticavity toothpaste | Sodium fluoride 1.5 mg/g | Gel, DentifriceDental | Church & Dwight Co., Inc. | 10237-732 |
| Colgate Total Whitening Charcoalstannous fluoride | Stannous fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-571 |
| Crest 3D White Glamorous Whitesodium fluoride | Sodium fluoride 1.6 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-914 |
| ZONSEN Gel Fluoridegel fluoride toothpaste | Sodium fluoride .22 g/100g | Gel, DentifriceDental | Wuhan Zonsen Medical Products Co., Ltd. | 72932-015 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeepsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-633 |
| Crest Complete Plus Scope Outlast Ultrasodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-918 |
| Brush Buddies Crayola Anticavity Fluoride Watermelonsodium fluoride | Sodium fluoride .02 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD | 73928-041 |
| AutoBrush Mintsodium fluoride | Sodium fluoride .243 g/100mL | LiquidOral | Lander Enterprises, LLC | 82913-011 |
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