Over-the-counter drug · OTC MONOGRAPH DRUG
Topicale (Benzocaine) NDC 10733-162
Benzocaine 180 mg/g · Ointment · Oral · Medical Products Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10733-162-35 | 10733016235 | 35 g in 1 CARTON (10733-162-35)Marketed from Mar 5, 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
- Ointment
- 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 10733-162_28dd1b61-76cb-9473-e063-6294a90a07ebSPL ID 28dd1b61-76cb-9473-e063-6294a90a07ebSPL set ID 82824416-80de-76bd-e053-2a91aa0ad8b5RxCUI 1042847, 1049224UNII U3RSY48JW5UPC 0064920649206
- 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
N410733016235followed by a unit qualifier and the quantityPackage 10733-0162-35. 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 10733-162
- What is NDC 10733-162?
- 10733-162 is the product NDC for Topicale (benzocaine), Benzocaine 180 mg/g ointment, 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 | PatchOral | Medical Products Laboratories, Inc. | 10733-173 | 10733-0173-01 |
| 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. | 10733-166 | 10733-0166-35 |
| 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 | GelOral | Medical Products Laboratories, Inc. | 10733-171 | 10733-0171-43 |
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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