Over-the-counter drug · OTC MONOGRAPH DRUG

Medline (Povidone-iodine) NDC 53329-125

Povidone-iodine 10 mg/mL · Swab · Topical · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-125Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0125Add 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
53329-125-09533290125091 APPLICATOR in 1 POUCH (53329-125-09) / 2.4 mL in 1 APPLICATORMarketed from Sep 1, 2024
53329-125-26533290125264 POUCH in 1 BOX (53329-125-26) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATORMarketed from Jan 1, 2025
53329-125-295332901252950 POUCH in 1 BOX (53329-125-29) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATORMarketed from Sep 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Medline
Generic name (nonproprietary)
povidone-iodine
Active ingredients
Povidone-iodine — 10 mg/mL
Dosage form
Swab
Route
Topical
Labeler
Medline Industries, LPNDC labeler code 53329
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 53329-125_561aa3d8-61dc-f8ea-e063-6294a90a96b9SPL ID 561aa3d8-61dc-f8ea-e063-6294a90a96b9SPL set ID 1d731a44-f16e-c249-e063-6294a90a39b8RxCUI 1300277UNII 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

N453329012509 followed by a unit qualifier and the quantity

Package 53329-0125-09. 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)

Uses for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53329-125

What is NDC 53329-125?
53329-125 is the product NDC for Medline (povidone-iodine), Povidone-iodine 10 mg/mL swab, listed with the FDA by Medline Industries, LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Povidone-iodine).
What is the active ingredient?
Povidone-iodine.
Who is the labeler?
Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline?
47 other product NDCs are listed under this name. See all Medline 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 Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineaspirinAspirin 81 mg/1Tablet, ChewableOralMedline Industries, LP53329-60153329-0601-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74

All 48 Medline NDCs

Other NDCs under 505G(a)(3)

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

FDA NDC Directory listings under 505G(a)(3)
ProductStrengthForm · routeLabelerProduct NDC
Asepso Herbal Scented AntisepticchloroxylenolChloroxylenol 2.5 mg/gSoapTopicalCODAA SWITZERLAND AG49698-009
Original Antisepticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralPublix Super Markets, Inc.56062-318
Anti Bacterial Hand Gel Perfect in PinkalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6767
Anti Bacterial Hand Gel Mango Papaya ParadisealcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7028
Smart Care 4 HAND SANITIZERS 1.35 FL OZ (MANGO PAPAYA, WATERMELON SPLASH, PINEAPPLE SUNRISE, COCONUT WATER)ethyl alcohol—KitAshtel Studios, Inc.70108-341
BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipesbenzalkonium chlorideBenzalkonium chloride 1.2 mg/mLClothTopicalQUEST USA CORP.78691-009
B Pure Moisturizing Hand Sanitizer Watermelon ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc80684-129
BZK Antiseptic Towelettebenzalkonium chloride clothBenzalkonium chloride 1.3 mg/gClothTopicalJINHUA JINGDI MEDICAL SUPPLIES CO., LTD83446-201
Tacruitf 5% minoxidil with biotin topical solutionminoxidilMinoxidil .05 g/mL; Biotin .002 g/mLSolutionTopicalGuangzhou Borderless Technology Co., Ltd.85304-028
serendipity3 4 PC Hand Sanitizer Set - Butter Chiffon, Lavender Milk, Cherry Blossom and Vanilla Honey SCENTethyl alcohol—KitDiamond Life Cosmetics Trading FZCO87247-943
Povidone Iodine Prep Solution Sterilepovidone-iodinePovidone-iodine 100 mg/mLSolutionTopicalJianerkang Medical Co., Ltd34645-0013
Pain Relieving Gel-PatchlidocaineLidocaine .04 g/gPatchTopicalShanghai Chuangshi Medical Technology (Group) Co., Ltd.73557-158
Asepso Sport AntisepticchloroxylenolChloroxylenol 2.5 mg/gSoapTopicalCODAA SWITZERLAND AG49698-006
Hand SanitizeralcoholAlcohol .879 mg/mLLiquidTopicalMedline Industries, LP53329-209
PurPreppovidone iodine and isopropyl alcoholIsopropyl alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mLSpongeTopicalCareFusion 213 LLC54365-014
ATTITUDE Super Leaves Hand Sanitizer Lemon Leavesethyl alcoholAlcohol 78.8 mL/100mLSolutionTopical9055-7588 Quebec Inc. DBA Attitude61649-293
Hyvee LHSbwenzalkonium chlorideBenzalkonium chloride 130 mg/100mLLiquidTopicalApollo Health and Beauty Care63148-326
Anti Bacterial Hand Gel Gingerbread BakeryalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6764
Anti Bacterial Hand Gel Pink Pineapple SunrisealcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7025
Witch HazelWitch hazel 86 g/100mLLiquidTopicalDealMed Medical Supplies LLC70082-008

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