Over-the-counter drug · OTC MONOGRAPH DRUG
CLARUS Antifungal (Tolnaftate) NDC 44577-470
Tolnaftate 10 mg/g · Cream · Topical · Clinical Therapeutic Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44577-470-00 | 4457704700044577047000 | 1 TUBE in 1 BOX (44577-470-00) / 85 g in 1 TUBEMarketed from Mar 11, 2024 |
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)
- CLARUS Antifungal
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Clinical Therapeutic SolutionsNDC labeler code 44577
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M
- Marketing start
- Listing expires
- Identifiers
- Product ID 44577-470_126eb818-7e35-3cce-e063-6294a90a5e69SPL ID 126eb818-7e35-3cce-e063-6294a90a5e69SPL set ID 835c3c23-fc3c-404e-8e87-5a0176126730RxCUI 103951UNII 06KB629TKVUPC 0859935003026
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
N444577047000followed by a unit qualifier and the quantityPackage 44577-0470-00. 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: For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.
Excerpt only. Read the full label for complete information.
About NDC 44577-470
- What is NDC 44577-470?
- 44577-470 is the product NDC for CLARUS Antifungal (tolnaftate), Tolnaftate 10 mg/g cream, listed with the FDA by Clinical Therapeutic Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CLARUS Antifungal (Tolnaftate).
- What is the active ingredient?
- Tolnaftate.
- Who is the labeler?
- Clinical Therapeutic Solutions, NDC labeler code 44577. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CLARUS Antifungal?
- 2 other product NDCs are listed under this name. See all CLARUS Antifungal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CLARUS Antifungal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CLARUS Antifungaltolnaftate | Tolnaftate 1 g/100g | CreamTopical | Clinical Therapeutic Solutions | 44577-001 | 44577-0001-01 |
| CLARUS Antifungaltolnaftate | Tolnaftate 1 g/100mL | SolutionTopical | Clinical Therapeutic Solutions | 44577-002 | 44577-0002-01 |
Other NDCs under M
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 |
|---|---|---|---|---|
| Broncochem Maximum Cough Kidsdextromethorphan hbr-guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL; Guaifenesin 100 mg/15mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-180 |
| Hydrocortisonehydrocortisone cream | Hydrocortisone acetate 10 mg/g | CreamTopical | HART Health | 50332-0092 |
| First Aid and Burnbenzalkonium chloride, lidocaine | Benzalkonium chloride .13 g/100g; Lidocaine .5 g/100g | CreamTopical | HART Health | 50332-0091 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0093 |
| Hand Sanitizerantiseptic gel | Alcohol 62 g/100g | GelTopical | HART Health | 50332-0094 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0095 |
| Therastatcherry cough drops | Menthol 5.8 mg/1 | LozengeOral | HART Health | 50332-0137 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | HART Health | 50332-0139 |
| CETAFEN COUGH and COLDacetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , | Guaifenesin 100 mg/1 + 3 more ingredients | Tablet, Film coatedOral | HART Health | 50332-0141 |
| Hand Sanitizer Solution 101benzalkonium chloride | Benzalkonium chloride 13 kg/100kg | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-224 |
| Histaprindiphenhydramine | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | NorMed | 50332-0150 |
| IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Richhomosalate, octisalate and octocrylene | Homosalate 100 mg/mL + 2 more ingredients | CreamTopical | LOreal USA Products Inc | 49967-904 |
| Cetafenacetaminophen | Acetaminophen 325 mg/1 | TabletOral | HART Health | 50332-0148 |
| MG DermaClean | Benzalkonium chloride .13 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-014 |
| MG FoamSan 70ethyl alcohol | Alcohol .7 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-223 |
| Cetafen Extraacetaminophen | Acetaminophen 500 mg/1 | TabletOral | HART Health | 50332-0149 |
| MG DermaGel 62ethyl alcohol | Alcohol .62 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-326 |
| Cetirzacetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | HART Health | 50332-0154 |
| MG DermaSan | Benzalkonium chloride .1 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-259 |
| Nutraloxcalcium carbonate | Calcium carbonate 420 mg/1 | Tablet, ChewableOral | HART Health | 50332-0151 |
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