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 Directory
Product 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 NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0395-9128-9800395912898003959128981 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

N400395912898 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Povidone Iodine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Povidone-IodinePovidone-iodine 100 mg/mLSolutionTopicalMajor Pharmaceuticals0904-763900904-7639-54
Povidone-IodinePovidone-iodine 10 mg/mLSolutionTopicalH E B37808-62437808-0624-34
Povidone-IodinePovidone-iodine 100 mg/mLSolutionTopicalCARDINAL HEALTH 110, LLC. DBA LEADER70000-075770000-0757-01
Povidone-IodinePovidone-iodine 10 mg/mLSolutionTopicalAcme United Corporation0924-540800924-5408-0100924-5408-02
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/1SwabTopicalTwinMed LLC55681-75255681-0752-00
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/1SwabTopicalTwinMed LLC55681-75355681-0753-00
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/gSwabTopicalTwinMed LLC55681-75155681-0751-00
Povidone Iodinepovidone iodine 10%Povidone-iodine 100 mg/gOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-11269396-0112-20
Povidone Iodinepovidone-iodinePovidone-iodine 100 mg/gOintmentTopicalDr Radows81584-110281584-1102-01
Povidone-IodinePovidone-iodine .1 mg/mLSwabTopicalMazza Healthcare, LLC81280-00281280-0002-01

All 29 Povidone Iodine NDCs

Other NDCs under M 003

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 003
ProductStrengthForm · routeLabelerProduct NDC
AntisepticethanolAlcohol .62 mL/mLGelTopicalMcKesson68599-5322
Hand sanitizer 16.9oz with vitamin Eethyl alcohol 70%Alcohol 70 mL/100mLLiquidTopicalZhejiang Guoyao Jingyue Aerosol Co., Ltd.75742-021
Mistify Pina Colada Hand Sanitezeralcohol antisepticAlcohol 62 mL/100mLLiquidTopicalKingkey MBC Life Technology Group Co.,Ltd73928-178
Solar Flare Hand Sanitizer Sunset SambaalcoholAlcohol 62 mL/100mLSprayTopicalScent Theory Products LLC76891-153
Klean Freakbenzalkonium chlorideBenzalkonium chloride .13 g/100gClothTopicalKLEAN FREAK, LLC78982-005
Guardellebenzalkonium chlorideBenzalkonium chloride .13 g/100mLAerosol, FoamTopicalSocial Medical Supply LLC85754-000
RITE AID Maximum strength pain relievingbenzalkonium chloride and lidocaine hydrochlorideBenzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mLLiquidTopicalRITE AID11822-7220
Hand SanitizerAlcohol 70 mL/100mLGelExtracorporealZhejiang Meimi Technology Co., Ltd.41366-055
Smart Care Cucumber Melon Hand SanitizeralcoholAlcohol 70 mL/100mLSprayTopicalShenzhen Lantern Scicence Co.,Ltd.54860-509
Walgreen Maximum strength pain relieving cleansingbenzalkonium chloride and lidocaine hydrochlorideBenzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mLLiquidTopicalWALGREENS CO.0363-7020
American Red Cross 70% Ethyl Alcohol Hand Sanitizerethyl alcoholAlcohol 70 mL/100mLGelTopicalZhejiang Guoyao Jingyue Aerosol Co., Ltd75742-018
Thompson Burn Cream with Lidocainebenzalkonium chloride, lidocaineLidocaine hydrochloride 5 mg/g; Benzalkonium chloride 1.3 mg/gCreamTopicalThompson Safety73408-160
Scentfull Hand Sanitizer Whipped CoconutalcoholAlcohol 62 mL/100mLSprayTopicalScent Theory Products LLC76891-150
Klean Freakbenzalkonium chlorideBenzalkonium chloride .13 g/100gClothTopicalKLEAN FREAK, LLC78982-002
Hand Sanitizeralcohol 62%Alcohol .62 g/gGelTopicalGuangzhou Ailizhuangsi Cosmetics Co., Ltd.87910-009
Obstetrical Towelettebenzalkonium chlorideBenzalkonium chloride 1.3 mg/gClothTopicalJianerkang Medical Co., Ltd34645-0015
Hand SanitizerAlcohol 70 mL/100mLGelExtracorporealZhejiang Meimi Technology Co., Ltd.41366-052
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Hibiscus Nectarethyl alcoholAlcohol 70 mL/100mLSprayTopicalMY IMPORTS USA LLC51628-4563
Soft Touch Plus Antibacterial Hand Item 1039chloroxylenolChloroxylenol .3 g/100mLSoapTopicalAMERICAN CHEMICAL AND SANITARY SUPPLY INC50536-139
Hydrogen PeroxideHydrogen peroxide 30 mg/mLSolutionTopicalPerrigo Direct, Inc50804-871

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