Over-the-counter drug · OTC MONOGRAPH DRUG

Miconazole Nitrate 2% (Jock itch spray) NDC 0363-5353

Miconazole nitrate 1.3 g/131g · Aerosol, Spray · Topical · Walgreens Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-5353Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-5353Add 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
0363-5353-000036353530000363535300131 g in 1 CAN (0363-5353-00)Marketed from Oct 28, 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)
Miconazole Nitrate 2%
Generic name (nonproprietary)
jock itch spray
Active ingredients
Miconazole nitrate — 1.3 g/131g
Dosage form
Aerosol, Spray
Route
Topical
Labeler
Walgreens CompanyNDC labeler code 0363
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 0363-5353_534c6399-4176-95bb-e063-6394a90abb76SPL ID 534c6399-4176-95bb-e063-6394a90abb76SPL set ID cf6cbaf4-beba-6fdf-e053-2995a90a76d2UNII VW4H1CYW1K
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

N400363535300 followed by a unit qualifier and the quantity

Package 00363-5353-00. 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 cures most jock itch (tinea cruris) relieves itching, burning 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 0363-5353

What is NDC 0363-5353?
0363-5353 is the product NDC for Miconazole Nitrate 2% (jock itch spray), Miconazole nitrate 1.3 g/131g aerosol, spray, listed with the FDA by Walgreens Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Miconazole Nitrate 2% (Jock Itch Spray).
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Miconazole Nitrate 2%?
1 other product NDC are listed under this name. See all Miconazole Nitrate 2% 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 Miconazole Nitrate 2% NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MICONAZOLE Nitrate 2%miconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalAkron Pharma Inc.71399-007171399-0071-0171399-0071-0371399-0071-04

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
CVS Health Athletes FoottolnaftateTolnaftate 10 mg/gCreamTopicalCVS Pharmacy, Inc.69842-336
TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-221
Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-108
Dr CANUSO fungal nail erasertolnaftate oilTolnaftate .3 g/28gOilTopicalRenu Laboratories, LLC76348-410
cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus penTolnaftate 1 g/100mL; Undecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-220
Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-106
Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-107
Hongo KillertolnaftateTolnaftate .1 g/10gAerosol, PowderTopicalEfficient Laboratories Inc58593-285
PedikleertolnaftateTolnaftate 1 g/100gCreamTopicalRising Pharma Holdings, Inc.57237-354
Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc56104-912
TolnaftateTolnaftate 10 mg/gCreamTopicalSheffield Pharmaceuticals LLC11527-051
THERA Antifungal Bodymiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalMcKesson Medical-Surgical Inc.68599-0207
LMNOOP MENS Private Health Creammens private health creamOatmeal 1 g/100gCreamTopicalShenzhen Ishan Technology Co., Ltd73076-210
Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalBeautivity LLC85398-036
Antifungal Bodymiconazole nitrateMiconazole nitrate 2 mg/100mLCreamTopicalMcKesson68599-0206
LYSSERA Fungal Nail Renewalundecylenic acid 25% antifungaUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-174
Anti-Fungal Powdermiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalThe Kroger Co.30142-947
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-329
Antifungal Medicated Body WashtolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-012
Vamy ANTIFUNGALtolnaftate 1% antifungalTolnaftate 1 g/100mLSprayTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-176

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