Over-the-counter drug · OTC MONOGRAPH DRUG
Cool Relief Oral Anesthetic (Menthol) NDC 54305-513
Menthol 13.2 mg/1 · Lozenge · Oral · Ricola Ag
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54305-513-10 | 54305051310 | 10 LOZENGE in 1 PACKAGE (54305-513-10)Marketed from Feb 1, 2020 |
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)
- Cool Relief Oral Anesthetic
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 13.2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Ricola AgNDC labeler code 54305
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 54305-513_688729fc-17f6-4022-82c3-6116973176baSPL ID 688729fc-17f6-4022-82c3-6116973176baSPL set ID 3698a69f-b5c0-4235-8ef8-71c867f1ac0dRxCUI 2277805UNII L7T10EIP3AUPC 0792554620109
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454305051310followed by a unit qualifier and the quantityPackage 54305-0513-10. 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 temporarily relieves occasional minor irritation and pain associated with sore mouth sore throat
Excerpt only. Read the full label for complete information.
About NDC 54305-513
- What is NDC 54305-513?
- 54305-513 is the product NDC for Cool Relief Oral Anesthetic (menthol), Menthol 13.2 mg/1 lozenge, listed with the FDA by Ricola Ag. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cool Relief Oral Anesthetic (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Ricola Ag, NDC labeler code 54305. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cool Relief Oral Anesthetic?
- 3 other product NDCs are listed under this name. See all Cool Relief Oral Anesthetic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cool Relief Oral Anesthetic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cool Relief Oral Anestheticmenthol | Menthol 13.2 mg/1 | LozengeOral | Ricola USA Inc. | 63667-513 | 63667-0513-10 |
| Cool Relief Oral Anestheticmenthol | Menthol 15.3 mg/1 | LozengeOral | Ricola Ag | 54305-153 | 54305-0153-1954305-0153-2454305-0153-45 |
| Cool Relief Oral Anestheticmenthol | Menthol 15.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-153 | 63667-0153-1963667-0153-2463667-0153-45 |
Other NDCs under M 022
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 |
|---|---|---|---|---|
| Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and menthol | Benzocaine 15 mg/1; Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-366 |
| Meijer Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | MEIJER DISTRIBUTION INC. | 41250-632 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-105 |
| Anadent Kanka Gelbenzocaine | Benzocaine 200 mg/g | GelDental | BELMORA LLC | 27854-177 |
| Rexall Maximum Strengthbenzocaine | Benzocaine 20 g/100mL | LiquidOral | Rexall | 55910-346 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0886 |
| Orajel 3X Medicated For All Mouth Soresbenzocaine, menthol, zinc chloride | Benzocaine 200 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-783 |
| Crest Kids Advanced Color Changingsodium monofluorophosphate | Sodium monofluorophosphate 1.6 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S de R.L. de C.V. | 58933-012 |
| Gelato Topical Anestheticbenzocaine | Benzocaine 11.4 g/57g | Spray, MeteredDental | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 68400-323 |
| Vicks Vapo Breathersmenthol | Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-320 |
| SENSODYNE PRONAMEL Active Shield Fresh Mintpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0700 |
| Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-376 |
| Ludens Honey Licorice Throat Dropsmenthol | Menthol 1.6 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-255 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-113 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Top Quality Manufacturing, Inc. | 69301-061 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-115 |
| Ludens Wild Cherry Throat Dropspectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-229 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| SENSODYNE Sensitivity Gum and Enamel Mintstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-5022 |
| Ludens Sugar Free Wild Cherry Throatpectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-249 |
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