Over-the-counter drug · OTC MONOGRAPH DRUG
Quala Topical Anesthetic Gel (Benzocaine) NDC 68400-478
Benzocaine 200 mg/g · Gel · Dental · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68400-478-30 | 68400047830 | 30 g in 1 JAR (68400-478-30)Marketed from Feb 3, 2022 |
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
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.NDC labeler code 68400
- 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 68400-478_2bd990f0-29c1-4e69-e063-6394a90a8a49SPL ID 2bd990f0-29c1-4e69-e063-6394a90a8a49SPL set ID d722bf24-ae85-54f6-e053-2995a90a1d35RxCUI 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
N468400047830followed by a unit qualifier and the quantityPackage 68400-0478-30. 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 68400-478
- What is NDC 68400-478?
- 68400-478 is the product NDC for Quala Topical Anesthetic Gel (benzocaine), Benzocaine 200 mg/g gel, listed with the FDA by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products 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?
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc., NDC labeler code 68400. 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 |
|---|---|---|---|---|
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2903 |
| LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Kenvue Brands LLC | 69968-0400 |
| Lolleez Watermelonpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3295 |
| meijer Sensitive FRESH MINTpotassium nitrate, sodium fluoride | Potassium nitrate 5 g/100g; Sodium fluoride .24 g/100g | Paste, DentifriceDental | Meijer, Inc. | 79481-0039 |
| parodontax Active Gum Repair Whiteningstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0638 |
| Opalescence Sensitivity Relief Whiteningpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-308 |
| Sensitivity Relief Fluoride Freepotassium nitrate | Potassium nitrate 50 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2105 |
| Sucrets Sore Throat Wild Cherrydyclonine hydrochloride | Dyclonine hydrochloride 2 mg/1 | LozengeOral | Insight Pharmaceuticals LLC | 63736-560 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-356 |
| Lemon Glyceringlycerin | Glycerin .3 g/4g | SwabOral | Dynarex Corporation | 67777-161 |
| Anesgerm LA MUELA Fast Pain Reliefbenzocaine 20% | Benzocaine 200 mg/mL | LiquidTopical | Germa Products, LLC | 73635-7101 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Extra Freshpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0486 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Opal by Opalescence Sensitivitypotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-311 |
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2901 |
| Sensitivity and Gum with Cavity Protectionpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 7.6 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2210 |
| Sucretsdyclonine hcl, menthol, and pectin | Dyclonine hydrochloride 2 mg/1 + 2 more ingredients | LozengeOral | Insight Pharmaceuticals LLC | 63736-567 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-357 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 150 mg/10mL | MouthwashTopical | CVS Pharmacy, Inc. | 69842-008 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
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