Over-the-counter drug · OTC MONOGRAPH DRUG
Opti-Nail 2-in-1 (Tolnaftate) NDC 55505-219
Tolnaftate 1 g/100mL · Liquid · Topical · Kramer Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55505-219-67 | 55505021967 | 5 mL in 1 TUBE, WITH APPLICATOR (55505-219-67)Marketed from Jan 20, 2023 |
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)
- Opti-Nail 2-in-1
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — 1 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Kramer LaboratoriesNDC labeler code 55505
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Marketing end
- Identifiers
- Product ID 55505-219_22f25809-6afc-43fc-81dc-de6745e20ab8SPL ID 22f25809-6afc-43fc-81dc-de6745e20ab8SPL set ID bc8a5492-8bd0-4c80-a270-e4958aeb5ed6RxCUI 313423, 2627287UNII 06KB629TKV
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
N455505021967followed by a unit qualifier and the quantityPackage 55505-0219-67. 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 proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete’s foot with daily use for effective relief of itching, burning and cracking.
Excerpt only. Read the full label for complete information.
About NDC 55505-219
- What is NDC 55505-219?
- 55505-219 is the product NDC for Opti-Nail 2-in-1 (tolnaftate), Tolnaftate 1 g/100mL liquid, listed with the FDA by Kramer Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Opti-Nail 2-in-1 (Tolnaftate).
- What is the active ingredient?
- Tolnaftate.
- Who is the labeler?
- Kramer Laboratories, NDC labeler code 55505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Opti-Nail 2-in-1?
- 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 |
|---|---|---|---|---|
| Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Target Corporation | 82442-998 |
| Tolnafatetolnaftate powder spray | Tolnaftate 10 mg/g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0607 |
| Antifungalclotrimazole | Clotrimazole 1 g/100g | CreamTopical | VIVE HEALTH LLC | 84722-3059 |
| Hermon Antifungal Cleansing Bartolnaftate 1% | Tolnaftate 4.52 g/452g | SoapTopical | Beautivity LLC | 85398-029 |
| Osimoon Fungal Nail Renewalfungal nail renewal | Undecylenic acid 10 g/100mL | LiquidTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-006 |
| Suave Antibacterial Hand Wash Sea Minerals and Aloe Veraliquid hand wash antibacterial | Benzalkonium chloride .13 g/100mL | LiquidTopical | Suave Brands Co, LLC | 83711-407 |
| Hermon Ringworm Antifungal soap.clotrimazole 1% | Clotrimazole 2.3 g/230g | SoapTopical | Beautivity LLC | 85398-026 |
| Anytalk FUNGAL NAIL TREATMENTtolnaftate 1% | Tolnaftate .01 mg/15mL | LiquidTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-181 |
| Tuymec FUNGAL NAIL TREATMENT Kitfungal nail treatment kit | Undecylenic acid 10 g/100mL | LiquidTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-004 |
| Antifungal Creammiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Encube Ethicals, Inc. | 21922-095 |
| Hand Sanitizerethyl alcohol | Alcohol 62 mL/100mL | GelTopical | Orazen Inc | 71927-005 |
| Jock Itchmiconazole nitrate | Miconazole nitrate 20 mg/g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0602 |
| Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Wal-Mart Stores, Inc. | 79903-256 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | Benzoyl peroxide 5 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-026 |
| Hermon Ringworm Treatment Kitmiconazole nitrate 2% and clotrimazole 1% | — | KitTopical | Beautivity LLC | 85398-027 |
| Kroger Jock Itchclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Kroger Company | 30142-510 |
| DCH Labs Antifungal Jockmiconazole nitrate 2% | Miconazole nitrate 2 g/100g | PowderTopical | Derma Care Research Labs, LLC | 72839-096 |
| FFPMAM Antifungal Cream | Clotrimazole 1 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-027 |
| Antifungalmiconazole | Miconazole 2 g/100g | PowderTopical | VIVE HEALTH LLC | 84722-3057 |
| Serynth Antifungal Nail Treatment Penundecylenic acid 25% antifungal nail treatment pen | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-165 |
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