Over-the-counter drug · OTC MONOGRAPH DRUG
Povi-One (Povidone-iodine 10% topical) NDC 57511-0611
Povidone-iodine 1 mg/10mL · Liquid · Topical · Elevate Oral Care
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57511-0611-2 | 5751106110257511061102 | 8 mL in 1 BOTTLE, DISPENSING (57511-0611-2)Marketed from Dec 18, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Povi-One
- Generic name (nonproprietary)
- povidone-iodine 10% topical
- Active ingredients
- Povidone-iodine — 1 mg/10mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Elevate Oral CareNDC labeler code 57511
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 57511-0611_3f28e924-0504-61d9-e063-6394a90abcedSPL ID 3f28e924-0504-61d9-e063-6394a90abcedSPL set ID 27c29a33-d1cc-d72f-e063-6394a90a4d45UNII 85H0HZU99M
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
N457511061102followed by a unit qualifier and the quantityPackage 57511-0611-02. 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)
Drug Facts Directions Drug Facts
Excerpt only. Read the full label for complete information.
About NDC 57511-0611
- What is NDC 57511-0611?
- 57511-0611 is the product NDC for Povi-One (povidone-iodine 10% topical), Povidone-iodine 1 mg/10mL liquid, listed with the FDA by Elevate Oral Care. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povi-One (Povidone-Iodine 10% topical).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Elevate Oral Care, NDC labeler code 57511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Povi-One?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxide | Hydrogen peroxide 3 mL/100mL | LiquidTopical | P & L Development, LLC | 49580-0268 |
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| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
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| Orajel Medicated for Toothache and Gum, Liquidbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mL | LiquidTopical | Church & Dwight Co., Inc. | 10237-796 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola Ag | 54305-301 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola USA Inc. | 63667-301 |
| Hydrogen Peroxide 3 Percenthydrogen peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Whole Foods Market | 42681-6414 |
| Sore throat cherryphenol | Phenol 1.4 g/100mL | SprayOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-376 |
| Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chloride | Cetylpyridinium chloride .07 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-648 |
| Crest Kids Advanced Color Changingsodium monofluorophosphate | Sodium monofluorophosphate 1.6 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S de R.L. de C.V. | 58933-012 |
| Sootheez Berry Lemonadepectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-4014 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1% | Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/g | GelTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-035 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Iodent Oral Analgesicbenzocaine | Benzocaine 200 mg/g | GelTopical | United Exchange Corp. | 65923-094 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Topcare Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | TOPCO ASSOCIATES LLC | 36800-606 |
| Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0580 |
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