Over-the-counter drug · OTC MONOGRAPH DRUG
BIOTENE Fresh Mint Original (sodium fluoride) NDC 0135-0557
Sodium fluoride 1.5 mg/g · Paste · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0557-01 | 00135055701 | 1 TUBE in 1 CARTON (0135-0557-01) / 121.9 g in 1 TUBEMarketed from Jul 15, 2013 | |
| 0135-0557-02 | 00135055702 | 1 TUBE in 1 CARTON (0135-0557-02) / 19.8 g in 1 TUBEMarketed from Jul 15, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- BIOTENE Fresh Mint OriginalSuffix: Fresh Mint Original
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 1.5 mg/g
- Dosage form
- Paste
- Route
- Oral
- Labeler
- Haleon US Holdings LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 0135-0557_95462fd1-5eb4-46ff-bf63-a5e610337bc6SPL ID 95462fd1-5eb4-46ff-bf63-a5e610337bc6SPL set ID 1101c17f-c848-4cd5-a7cd-679b59dbe1bfRxCUI 416783, 1044547UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400135055701followed by a unit qualifier and the quantityPackage 00135-0557-01. 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)
Use aids in the prevention of dental cavities
Excerpt only. Read the full label for complete information.
Other NDCs under M 022
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 |
|---|---|---|---|---|
| Finafta MultiOralbenzocaine | Benzocaine 7.5 mg/100mL | SprayOral | Efficient Laboratories Inc. | 58593-782 |
| DenTek Instant Pain Relief Maximum Strengthbenzocaine | Benzocaine 200 mg/mL | LiquidDental, Topical | DenTek Oral Care, Inc. | 60630-078 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-102 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Natural Cherry Honey Herb Throat Dropsmenthol | Menthol 2.1 mg/1 | LozengeOral | Ricola USA Inc. | 63667-517 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0009 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0622 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-100 |
| Toothachepolyhexamethylene biguanide hydrochloride | Polihexanide hydrochloride .25 g/100mL | SprayTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-012 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 15 mg/mL | MouthwashTopical | Meijer, Inc. | 41250-750 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0010 |
| Cherry Throat Dropsmenthol | Menthol 1.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-518 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-101 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mintsodium bicarbonate | Sodium bicarbonate 25 mg/mL | LiquidOral | Lotus Brands, Inc. | 76328-223 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshenercetylpyridinium chloride | Cetylpyridinium chloride 70 mg/mL | LiquidOral | Haleon US Holdings LLC | 0135-0652 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1014 |
| Natural Lemon Mint Herb Throat Dropsmenthol | Menthol 1.5 mg/1 | LozengeOral | Ricola Ag | 54305-489 |
| Quality Choice Maximum Strength Oral Pain Relievingbenzocaine | Benzocaine 20 g/100g | GelTopical | Chain Drug Marketing Association Inc | 63868-953 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1011 |
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