Over-the-counter drug · OTC MONOGRAPH DRUG

Medline (Miconazole nitrate) NDC 53329-256

Miconazole nitrate 20 mg/g · Ointment · Topical · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-256Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0256Add 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
53329-256-14533290256145332902561457 g in 1 TUBE (53329-256-14)Marketed from Aug 5, 2026
53329-256-645332902566453329025664142 g in 1 TUBE (53329-256-64)Marketed from Aug 5, 2026

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)
miconazole nitrate
Active ingredients
Miconazole nitrate — 20 mg/g
Dosage form
Ointment
Route
Topical
Labeler
Medline Industries, LPNDC labeler code 53329
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 53329-256_509fcf56-d5a6-6adb-e063-6394a90a0be4SPL ID 509fcf56-d5a6-6adb-e063-6394a90a0be4SPL set ID 3c43ef91-bbd2-5e58-e063-6294a90a00d3RxCUI 998442UNII VW4H1CYW1KUPC 0197344161747
Pharmacologic class
Azole Antifungal

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

N453329025614 followed by a unit qualifier and the quantity

Package 53329-0256-14. 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 the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53329-256

What is NDC 53329-256?
53329-256 is the product NDC for Medline (miconazole nitrate), Miconazole nitrate 20 mg/g ointment, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Miconazole nitrate).
What is the active ingredient?
Miconazole nitrate.
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?
46 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
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
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
Medlinezinc oxideZinc oxide 200 mg/gPasteTopicalMedline Industries, LP53329-25553329-0255-0553329-0255-10
MedlinedimethiconeDimethicone 2 g/100mLLotionTopicalMedline Industries, LP53329-25153329-0251-18

All 47 Medline NDCs

Other NDCs under M 005

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

FDA NDC Directory listings under M 005
ProductStrengthForm · routeLabelerProduct NDC
Tolnafatetolnaftate athletes foot powder spray talc freeTolnaftate 1.3 g/130gAerosol, SprayTopicalVALU MERCHANDISERS, CO63941-541
U Hand Sanitizer Classicbenzalkonium chlorideBenzalkonium chloride .13 g/100mLSolutionTopicalBLUE SEA AEROSOL & DAILY CARE CO., LTD72119-004
Gembooxt Nail Fungus SolutionUndecylenic acid 11 g/100mLLiquidTopicalGuangdong Quadrant Ecological Technology Co., Ltd.76986-016
Nailtific Nighttime Antifungal Renewal Pen RefilltolnaftateTolnaftate .06 g/6mLLiquidTopicalGuangzhou Meixi Biotechnology Co., Ltd.84167-023
UKVOA Toenail Fungus Treatmenttolnaftate 1% fungi nailTolnaftate 1 g/100mLLiquidTopicalJiashen International Trade Limited84867-012
Tegasolve Toenail Fungus Treatmentundecylenic acid 25%Undecylenic acid 25 g/100mLLiquidTopicalZhengzhou Hangrui Network Technology Co., Ltd.85578-003
Tuymec Antifungal Medicated Barantifungal medicated barClotrimazole 1 g/100gSoapTopicalGuangzhou Jingliang Cosmetics Co., Ltd.87408-010
Lotrimin Daily PreventiontolnaftateTolnaftate 10 mg/gPowderTopicalBayer HealthCare LLC.11523-0011
Green Tetterinemiconazole nitrateMiconazole nitrate 2 g/100gOintmentTopicalS.S.S. Company12258-241
COTTON ON FOUNDATION Coastal Hand Sanitizerethyl alcoholAlcohol 75 mL/100mLSprayTopicalNantong Health & Beyond Hygienic Products Inc.43473-052
VORVITA Nail Hardenerpanthenol,hyaluronic acidHyaluronic acid 1 g/10000mL; Panthenol 10 g/10000mLSolutionTopicalHK Vorvita Technology Co., Limited87690-001
MOROVANJock Itch Antifungalmiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalHONG KONG UNORDERED TRADING CO., LIMITED87800-0006
White Tetterinemiconazole nitrateMiconazole nitrate 2 g/100gOintmentTopicalS.S.S. Company12258-242
Bluesea Disposable Hand SanitizeralcoholAlcohol 75 mL/100mLSolutionTopicalBLUE SEA AEROSOL & DAILY CARE CO., LTD72119-002
Nailtific Daytime Treatment Antifungal Pen RefillUndecylenic acid 1.5 g/6mL; Tolnaftate .06 g/6mLLiquidTopicalGuangzhou Meixi Biotechnology Co., Ltd.84167-012
Skin Tag Wart And Corn Removersalicylic acidSalicylic acid 17 g/100gLiquidCutaneous, Extracorporeal, TopicalZhenping Renren Industry Co., Ltd.87096-001
Lakeim FUNGAL NAIL RENEWAL Kitfungal nail renewal kitUndecylenic acid 25 g/100mLLiquidTopicalGuangzhou Jingliang Cosmetics Co., Ltd.87408-009
Tingole Fungal Nail Patchesfungal nail patchesTolnaftate 1 g/1001PatchTopicalXiamen Jingwei Supply Chain Management Co., Ltd88010-002
Tolnafatetolnaftate jock itch powder spray - talc freeTolnaftate 1.3 g/130gAerosol, SprayTopicalVALU MERCHANDISERS, CO.63941-540
Bluesea Instant Hand SanitizeralcoholAlcohol 70 mL/100mLSolutionTopicalBLUE SEA AEROSOL & DAILY CARE CO., LTD72119-003

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