Over-the-counter drug · OTC MONOGRAPH DRUG
Zeasorb Jock Itch (Miconazole nitrate) NDC 0316-8001
Miconazole nitrate 20 mg/g · Powder · Topical · Crown Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0316-8001-02 | 0031680010200316800102 | 71 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
N400316800102followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lavender Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-015 |
| Sefudun Fungal Nail Patchesglycerin | Glycerin .01 g/1 | PatchTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-006 |
| Hongo Killertolnaftate | Miconazole nitrate .2 g/10g | Aerosol, SprayTopical | Efficient Laboratories Inc | 58593-625 |
| Lights Isopropyl Alcohol Prep Padsisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | SolutionTopical | Lights Medical Manufacture Co., Ltd. | 61333-206 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1000 |
| Tolnaftatemeijer athletes foot liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0591 |
| Mint Blast Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-013 |
| NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-202 |
| Benzo Dermabenzoic acid, salicylic acid, sulfur | Salicylic acid 2.5 g/100g + 2 more ingredients | CreamTopical | LABORATORIOS H.G. C.A. | 84058-130 |
| SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrate | Miconazole nitrate 20 mg/g | CreamTopical | Strategic Sourcing Services LLC | 49348-689 |
| Hongo Killertolnaftate | Tolnaftate 1 g/100g | PowderTopical | Efficient Laboratories Inc | 58593-288 |
| Mycozyl ALtolnaftate | Tolnaftate .3 g/30mL | LiquidTopical | PureTek Corporation | 59088-443 |
| Tolnaftate Cream 1%tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Pharmacy Value Alliance, LLC. | 68016-152 |
| Citrus Detox Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-014 |
| Antifungal Ringworm Treatmentmiconazole nitrate | Miconazole nitrate 2 g/100mL | SprayTopical | Rida LLC | 83004-030 |
| Jock-Ezeclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Bentlin Products LLC | 47832-071 |
| Maximum Strength Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Walgreens Company | 0363-2026 |
| QualiLife persimmon foot and shoeundecylenic acid | Undecylenic acid 10 g/100mL | SprayTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-618 |
| Terramed Just Think Comfort Armor Antifungal Body Wash Tea Treetolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-032 |
| Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatment | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-204 |
Showing 20 of 40.