Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine (Povidone iodine oral rinse 0.5%) NDC 0395-9136
Povidone-iodine 5 mg/mL · Liquid · Topical · Humco Holding Group, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0395-9136Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00395-9136Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0395-9136-23 | 0039591362300395913623 | 20 mL in 1 CONTAINER (0395-9136-23)Marketed from Oct 1, 2021 | |
| 0395-9136-98 | 0039591369800395913698 | 237 mL in 1 CONTAINER (0395-9136-98)Marketed from Jan 6, 2021 |
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)
- Povidone Iodine
- Generic name (nonproprietary)
- povidone iodine oral rinse 0.5%
- Active ingredients
- Povidone-iodine — 5 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Humco Holding Group, Inc.NDC labeler code 0395
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 0395-9136_0c93bae9-c6ed-1fc7-e063-6394a90adea9SPL ID 0c93bae9-c6ed-1fc7-e063-6394a90adea9SPL set ID b83dbdd1-ff63-caf8-e053-2a95a90a5764RxCUI 314935UNII 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
N400395913623followed by a unit qualifier and the quantityPackage 00395-9136-23. 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 For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.
Excerpt only. Read the full label for complete information.
About NDC 0395-9136
- What is NDC 0395-9136?
- 0395-9136 is the product NDC for Povidone Iodine (povidone iodine oral rinse 0.5%), Povidone-iodine 5 mg/mL liquid, listed with the FDA by Humco Holding Group, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone Iodine (Povidone Iodine Oral Rinse 0.5%).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Humco Holding Group, Inc., NDC labeler code 0395. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Povidone Iodine?
- 28 other product NDCs are listed under this name. See all Povidone Iodine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Povidone Iodine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Povidone-Iodine | Povidone-iodine 100 mg/mL | SolutionTopical | Major Pharmaceuticals | 0904-7639 | 00904-7639-54 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | H E B | 37808-624 | 37808-0624-34 |
| Povidone-Iodine | Povidone-iodine 100 mg/mL | SolutionTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0757 | 70000-0757-01 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | Acme United Corporation | 0924-5408 | 00924-5408-0100924-5408-02 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-752 | 55681-0752-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-753 | 55681-0753-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/g | SwabTopical | TwinMed LLC | 55681-751 | 55681-0751-00 |
| Povidone Iodinepovidone iodine 10% | Povidone-iodine 100 mg/g | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-112 | 69396-0112-20 |
| Povidone Iodinepovidone-iodine | Povidone-iodine 100 mg/g | OintmentTopical | Dr Radows | 81584-1102 | 81584-1102-01 |
| Povidone-Iodine | Povidone-iodine .1 mg/mL | SwabTopical | Mazza Healthcare, LLC | 81280-002 | 81280-0002-01 |
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 |
|---|---|---|---|---|
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Organic Peppermint Herb Throat Dropsmenthol | Menthol 1.9 mg/1 | LozengeOral | Ricola USA Inc. | 63667-010 |
| Equate Sculpted White TP Equate Sculpted White TPsodium fluoride | Sodium fluoride .15 g/100g | Paste, DentifriceOral | Walmart | 79903-282 |
| Ki No Sincalcium carbonate | Calcium carbonate 55 mg/500mg | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-322 |
| R B onephosphatidylserine, zinc oxide | Zinc oxide 6.38 mg/1100mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-140 |
| Sensodynepotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0550 |
| parodontaxstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0598 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Alzh Lphosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-230 |
| Topicalebenzocaine | Benzocaine 180 mg/g | OintmentOral | Medical Products Laboratories, Inc. | 10733-162 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | Paste, DentifriceTopical | Walgreens | 0363-5337 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Walgreens | 0363-5820 |
| Dem Zerophosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-240 |
| Benzoin Tincturebenzoin resin | Benzoin resin 1000 mg/mL | LiquidTopical | 116956644 | 70677-1200 |
| Rite Aid Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-0345 |
| Chloraseptic Sore Throat Citrusphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-112 |
| Sore Throat Relief Cherry Flavorphenol | Phenol 1.4 g/100mL | SprayOral | Cardinal Health | 70000-0458 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0293 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| Benzocaine 20% | Benzocaine 200 mg/mL | SolutionTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1077 |
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