Over-the-counter drug · OTC MONOGRAPH DRUG
Topicale (Benzocaine) NDC 10733-173
Benzocaine 180 mg/g · Patch · Oral · Medical Products Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10733-173-01 | 10733017301 | 5 g in 1 CARTON (10733-173-01)Marketed from May 6, 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)
- Topicale
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 180 mg/g
- Dosage form
- Patch
- Route
- Oral
- Labeler
- Medical Products Laboratories, Inc.NDC labeler code 10733
- 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 10733-173_29694bac-976b-0291-e063-6394a90a32d1SPL ID 29694bac-976b-0291-e063-6394a90a32d1SPL set ID 8282a4a6-b77c-75fc-e053-2991aa0ad4acUNII 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 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
N410733017301followed by a unit qualifier and the quantityPackage 10733-0173-01. 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)
For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Excerpt only. Read the full label for complete information.
About NDC 10733-173
- What is NDC 10733-173?
- 10733-173 is the product NDC for Topicale (benzocaine), Benzocaine 180 mg/g patch, listed with the FDA by Medical Products Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topicale (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Medical Products Laboratories, Inc., NDC labeler code 10733. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topicale?
- 6 other product NDCs are listed under this name. See all Topicale NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topicale products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-169 | 10733-0169-43 |
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-171 | 10733-0171-43 |
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-167 | 10733-0167-43 |
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-170 | 10733-0170-43 |
| Topicalebenzocaine | Benzocaine 180 mg/g | OintmentOral | Medical Products Laboratories, Inc. | 10733-162 | 10733-0162-35 |
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-166 | 10733-0166-35 |
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 |
|---|---|---|---|---|
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-171 |
| Cepacol Extra Strength Sore Throat cherrybenzocaine and menthol | Benzocaine 15 mg/1; Menthol, Unspecified form 3.6 mg/1 | LozengeOral | Reckitt Benckiser LLC | 63824-713 |
| Hydrogen Peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Safeway, Inc. | 21130-979 |
| Fishermans Friend Orange Gingermenthol | Menthol 5 mg/1 | LozengeOral | Lofthouse of Fleetwood | 55711-101 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Wintergreen Peppermintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | Twice Twice LLC | 72164-005 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0522 |
| Betadine Garglepovidone-iodine | Povidone-iodine .05 mg/mL | SolutionOral | Atlantis Consumer Healthcare, Inc. | 67618-181 |
| Sore Throat Cherryphenol | Phenol 1.4 g/100mL | SprayOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-811 |
| Orajel 2X Medicated Geloral pain reliever | Benzocaine 200 mg/g; Menthol 2.6 mg/g | GelTopical | Church & Dwight Co., Inc. | 10237-782 |
| NATEAN Clean plus Sensitivity Reliefpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteOral | Haleon US Holdings LLC | 0135-1250 |
| Meijer Enamel Guardpotassium nitrate, sodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | Meijer Distribution Inc | 41250-514 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 1588 mg/mL | MouthwashTopical | Rite Aid Corporation | 11822-1462 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-101 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-104 |
| Made by Dentists Sensitive and Whitening Fresh Mintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-029 |
| Benzo-Jelbenzocaine | Benzocaine 200 mg/g | GelDental | Henry Schein Inc. | 0404-0036 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-102 |
| CVS Health Sore Throat Fast Relief Oral Anestheticphenol | Phenol 1.4 g/100mL | SprayOral | CVS Pharmacy,Inc. | 59779-895 |
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