Over-the-counter drug · OTC MONOGRAPH DRUG
Quala Topical Anesthetic Gel (Benzocaine) NDC 43128-033
Benzocaine 200 mg/g · Gel · Dental · National Distribution & Contracting, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43128-033-30 | 4312800333043128003330 | 30 g in 1 JAR (43128-033-30)Marketed from Oct 1, 2019 |
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)
- Quala Topical Anesthetic Gel
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 200 mg/g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- National Distribution & Contracting, IncNDC labeler code 43128
- 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 43128-033_4d3b1d53-224a-5a47-e063-6394a90a1943SPL ID 4d3b1d53-224a-5a47-e063-6394a90a1943SPL set ID 9f9490c1-8bfe-3166-e053-2a95a90a7175RxCUI 238910UNII U3RSY48JW5
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N443128003330followed by a unit qualifier and the quantityPackage 43128-0033-30. 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 For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Excerpt only. Read the full label for complete information.
About NDC 43128-033
- What is NDC 43128-033?
- 43128-033 is the product NDC for Quala Topical Anesthetic Gel (benzocaine), Benzocaine 200 mg/g gel, listed with the FDA by National Distribution & Contracting, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quala Topical Anesthetic Gel (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- National Distribution & Contracting, Inc, NDC labeler code 43128. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quala Topical Anesthetic Gel?
- 10 other product NDCs are listed under this name. See all Quala Topical Anesthetic Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quala Topical Anesthetic Gel products
Other finished products listed under the same name: strengths, forms and labelers.
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 |
|---|---|---|---|---|
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Organic Peppermint Herb Throat Dropsmenthol | Menthol 1.9 mg/1 | LozengeOral | Ricola USA Inc. | 63667-010 |
| Equate Sculpted White TP Equate Sculpted White TPsodium fluoride | Sodium fluoride .15 g/100g | Paste, DentifriceOral | Walmart | 79903-282 |
| Ki No Sincalcium carbonate | Calcium carbonate 55 mg/500mg | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-322 |
| R B onephosphatidylserine, zinc oxide | Zinc oxide 6.38 mg/1100mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-140 |
| Sensodynepotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0550 |
| parodontaxstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0598 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Alzh Lphosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-230 |
| Topicalebenzocaine | Benzocaine 180 mg/g | OintmentOral | Medical Products Laboratories, Inc. | 10733-162 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | Paste, DentifriceTopical | Walgreens | 0363-5337 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Walgreens | 0363-5820 |
| Dem Zerophosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-240 |
| Benzoin Tincturebenzoin resin | Benzoin resin 1000 mg/mL | LiquidTopical | 116956644 | 70677-1200 |
| Rite Aid Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-0345 |
| Chloraseptic Sore Throat Citrusphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-112 |
| Sore Throat Relief Cherry Flavorphenol | Phenol 1.4 g/100mL | SprayOral | Cardinal Health | 70000-0458 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0293 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| Benzocaine 20% | Benzocaine 200 mg/mL | SolutionTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1077 |
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