Over-the-counter drug · OTC MONOGRAPH DRUG
Topcare Maximum Strength (Benzocaine) NDC 36800-443
Benzocaine 20 g/100g · Liquid · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-443Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0443Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-443-58 | 3680004435836800044358 | 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATORMarketed from Oct 1, 2014 |
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)
- Topcare Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 20 g/100g
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 36800-443_5d30e185-1cc3-2777-e063-6394a90a7577SPL ID 5d30e185-1cc3-2777-e063-6394a90a7577
- Pharmacologic class
- Standardized Chemical Allergen
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
N436800044358followed by a unit qualifier and the quantityPackage 36800-0443-58. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 36800-443
- What is NDC 36800-443?
- 36800-443 is the product NDC for Topcare Maximum Strength (benzocaine), Benzocaine 20 g/100g liquid, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare Maximum Strength (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topcare Maximum Strength?
- 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 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 |
|---|---|---|---|---|
| Oral Gel Oral Pain Reliefbenzocaine benzalkonium chloride | Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g | GelTopical | Savvy Care and Cosmetics | 83650-101 |
| Boka Sensitivepotassium nitrate | Potassium nitrate 5 g/100g | Paste, DentifriceDental | Karaka LLC | 87161-444 |
| Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0580 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Chloraseptic Childrens Sore Throat Cherryphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-930 |
| Quality Choicebenzocaine | Benzocaine 200 mg/g | GelTopical | Chain Drug Marketing Association, Inc. | 83324-299 |
| Chloraseptic Sore Throat Maxphenol and glycerin | Phenol 15 mg/mL; Glycerin 330 mg/mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-937 |
| Orajel 3X Medicated For Toothache and Gumbenzocaine, menthol, zinc chloride | Menthol 2.6 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-790 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | LiquidOral | WALMART INC. (see also Equate) | 79903-151 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefbenzocaine and menthol, unspecified form | Benzocaine 7 g/100mL; Menthol, Unspecified form 1 g/100mL | SprayOral | Reckitt Benckiser LLC | 72854-265 |
| HEB Extra Whiteningfluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | HEB | 37808-961 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0005 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefhexylresorcinol | Hexylresorcinol 2 mg/1 | LozengeOral | Reckitt Benckiser LLC | 72854-262 |
| Crest Scope Originalcetylpyridinium chloride | Cetylpyridinium chloride .014 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-602 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0006 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0920 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0007 |
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