NDC codes

FDA NDC Directory
Product NDC (as listed)0316-8001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00316-8001Add 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
0316-8001-02003168001020031680010271 g in 1 BOTTLE, PLASTIC (0316-8001-02)Marketed from Oct 19, 2023

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)
Zeasorb Jock Itch
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 20 mg/g
Dosage form
Powder
Route
Topical
Labeler
Crown LaboratoriesNDC labeler code 0316
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 0316-8001_4833f63f-c8ac-19bf-e063-6394a90abcdcSPL ID 4833f63f-c8ac-19bf-e063-6394a90abcdcSPL set ID 09d088ef-aab3-5565-e063-6394a90af263RxCUI 998461, 1437793UNII 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

N400316800102 followed by a unit qualifier and the quantity

Package 00316-8001-02. 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 Proven clinically effective in the treament of most jock itch

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0316-8001

What is NDC 0316-8001?
0316-8001 is the product NDC for Zeasorb Jock Itch (miconazole nitrate), Miconazole nitrate 20 mg/g powder, listed with the FDA by Crown Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zeasorb Jock Itch (Miconazole nitrate).
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
Crown Laboratories, NDC labeler code 0316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zeasorb Jock Itch?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Lavender Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-015
Sefudun Fungal Nail PatchesglycerinGlycerin .01 g/1PatchTopicalShenzhen Shandian Jingling Technology Co., Ltd.83804-006
Hongo KillertolnaftateMiconazole nitrate .2 g/10gAerosol, SprayTopicalEfficient Laboratories Inc58593-625
Lights Isopropyl Alcohol Prep Padsisopropyl alcoholIsopropyl alcohol 70 mL/100mLSolutionTopicalLights Medical Manufacture Co., Ltd.61333-206
Miconazole NitrateMiconazole nitrate 20 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-1000
Tolnaftatemeijer athletes foot liquid sprayTolnaftate 1.5 g/150gAerosol, SprayTopicalMeijer Distribution Inc.79481-0591
Mint Blast Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-013
NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-202
Benzo Dermabenzoic acid, salicylic acid, sulfurSalicylic acid 2.5 g/100g + 2 more ingredientsCreamTopicalLABORATORIOS H.G. C.A.84058-130
SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrateMiconazole nitrate 20 mg/gCreamTopicalStrategic Sourcing Services LLC49348-689
Hongo KillertolnaftateTolnaftate 1 g/100gPowderTopicalEfficient Laboratories Inc58593-288
Mycozyl ALtolnaftateTolnaftate .3 g/30mLLiquidTopicalPureTek Corporation59088-443
Tolnaftate Cream 1%tolnaftateTolnaftate 10 mg/gCreamTopicalPharmacy Value Alliance, LLC.68016-152
Citrus Detox Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-014
Antifungal Ringworm Treatmentmiconazole nitrateMiconazole nitrate 2 g/100mLSprayTopicalRida LLC83004-030
Jock-EzeclotrimazoleClotrimazole 10 mg/gCreamTopicalBentlin Products LLC47832-071
Maximum Strength Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalWalgreens Company0363-2026
QualiLife persimmon foot and shoeundecylenic acidUndecylenic acid 10 g/100mLSprayTopicalGuangdong Aimu Biological Technology Co., Ltd83566-618
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreetolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-032
Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatmentUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-204

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