Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine (Povidone iodine gargle 0.5%) NDC 0395-9128
Povidone-iodine 5 mg/mL · Liquid · Topical · Humco Holding Group, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0395-9128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00395-9128Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0395-9128-98 | 0039591289800395912898 | 1 CONTAINER in 1 CARTON (0395-9128-98) / 237 mL in 1 CONTAINERMarketed from Jun 10, 2020 |
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 gargle 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 003
- Marketing start
- Listing expires
- Identifiers
- Product ID 0395-9128_0c9380d5-c284-0902-e063-6394a90ac157SPL ID 0c9380d5-c284-0902-e063-6394a90ac157SPL set ID a7b9ad55-cfeb-6066-e053-2a95a90af975RxCUI 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
N400395912898followed by a unit qualifier and the quantityPackage 00395-9128-98. 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 the temporary relief of occasional sore throat.
Excerpt only. Read the full label for complete information.
About NDC 0395-9128
- What is NDC 0395-9128?
- 0395-9128 is the product NDC for Povidone Iodine (povidone iodine gargle 0.5%), Povidone-iodine 5 mg/mL liquid, listed with the FDA by Humco Holding Group, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone Iodine (Povidone Iodine Gargle 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 003
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 |
|---|---|---|---|---|
| Hydrating Hand Sanitizer ALOE BREEZEalcohol 75% | Alcohol .75 g/mL | LiquidTopical | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 87910-005 |
| palm partyalcohol hand sanitizer | Alcohol 60 mL/100mL | SprayTopical | Dongyang Loulee Cosmetics Co.,Ltd. | 87322-1169 |
| Isopropyl Alcohol | Isopropyl alcohol 70 mL/100mL | ClothTopical | Sarnova, Inc. | 81085-0002 |
| Terramed Just Think Comfort Armor Antibacterial Cleansing Barbenzalkonium chloride | Benzalkonium chloride .13 g/100g | SoapTopical | Rida LLC | 83004-033 |
| Antiseptic Povidone Iodine Prep Padpovidone-iodine | Povidone-iodine 100 mg/g | ClothTopical | M-star (Hubei) Health&Care Products Co., Ltd. | 84219-006 |
| Green Guard Antiseptic Wipesbenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | SwabTopical | UniFirst First Aid Corporation | 47682-206 |
| RITE AID Maximum strength pain relievingbenzalkonium chloride and lidocaine hydrochloride | Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL | LiquidTopical | RITE AID | 11822-7220 |
| Obstetrical Towelettebenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | ClothTopical | Jianerkang Medical Co., Ltd | 34645-0015 |
| Hand Sanitizer | Alcohol 70 mL/100mL | GelExtracorporeal | Zhejiang Meimi Technology Co., Ltd. | 41366-053 |
| 50 percent Isopropyl alcoholisopropyl alcohol | Isopropyl alcohol 50 mL/100mL | LiquidTopical | Whole Foods Market | 42681-6573 |
| Antibacterial Hand wipesbenzalkonium chloride | Benzalkonium chloride .13 g/100g | ClothTopical | MY IMPORTS USA LLC | 51628-9999 |
| E-2 Hand Item 1095chloroxylenol | Chloroxylenol .3 g/100mL | SoapTopical | AMERICAN CHEMICAL AND SANITARY SUPPLY INC | 50536-195 |
| Smart Care Kids Hand Sanitizer Peppa pigalcohol | Alcohol 70 mL/100mL | SprayTopical | Shenzhen Lantern Scicence Co.,Ltd. | 54860-513 |
| Be Smart Get Prepared Alcohol Prep Padisopropyl alcohol | Isopropyl alcohol .7 mL/mL | ClothTopical | Total Resources International, Inc | 55550-242 |
| McKesson Alcohol Prep Padisopropyl alcohol | Isopropyl alcohol .7 mL/mL | SwabTopical | McKesson Medical-Surgical | 68599-5804 |
| AshleyBelle Moisturizing Hand Sanitizer Citrus Groveethyl alcohol 70% | Alcohol 70 mL/100mL | SprayTopical | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 75742-041 |
| Mistify Pumpkin Hand Sanitizeralcohol antiseptic | Alcohol 62 mL/100mL | LiquidTopical | Kingkey MBC Life Technology Group Co.,Ltd | 73928-313 |
| Hydrogen Peroxide | Hydrogen peroxide 30 mg/mL | SolutionTopical | Grocery Outlet, Inc. | 85828-871 |
| Antiseptic Towelette TOALLITAS ANTISEPTICASbenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | ClothTopical | M-star (Hubei) Health&Care Products Co., Ltd. | 84219-004 |
| Isopropyl alcohol | Isopropyl alcohol 70 mL/100mL | LiquidTopical | Nice-Pak Products, LLC | 11344-845 |
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