Over-the-counter drug · OTC MONOGRAPH DRUG
Topicale (Benzocaine) NDC 10733-166
Benzocaine 180 mg/g · Gel · Oral · Medical Products Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10733-166-35 | 10733016635 | 35 g in 1 CARTON (10733-166-35)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
- Gel
- 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 10733-166_28dd05fd-da61-a52d-e063-6394a90afe83SPL ID 28dd05fd-da61-a52d-e063-6394a90afe83SPL set ID 826eaef8-4457-3dc2-e053-2991aa0a528bRxCUI 1042838, 1049213UNII U3RSY48JW5UPC 0064881648812
- 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
N410733016635followed by a unit qualifier and the quantityPackage 10733-0166-35. 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 10733-166
- What is NDC 10733-166?
- 10733-166 is the product NDC for Topicale (benzocaine), Benzocaine 180 mg/g gel, 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. | 10733-171 | 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 |
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 |
|---|---|---|---|---|
| Tiger Supply Inc Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Tiger Supply Inc. | 69484-002 |
| Sensodyne Pronamel Strong and Bright Enamel Extra Freshpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0603 |
| parodontax Complete Protectionstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0634 |
| Lolleez Strawberrypectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3395 |
| DG 4x Medicated Tooth and Gum Creambenzocaine | Zinc chloride .15 g/100g + 3 more ingredients | CreamOral | Dollar General | 55910-660 |
| Dental City Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | ICP Inc DBA Dental City | 69483-008 |
| Top Care Enamel Guardfluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | TOPCO Assoc. LLC | 36800-681 |
| Lolleez Watermelonpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3295 |
| Saline | Sodium chloride 6.5 mg/mL | SprayNasal | FAMILY DOLLAR SERVICES INC | 55319-047 |
| Dental City Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | ICP Inc DBA Dental City | 69483-009 |
| JAYSUING Colour Correctorglycerin | Chamomile .006 mg/30mg | LiquidTopical | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 85060-006 |
| Lolleez Watermelonpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3295 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | Gel, DentifriceOral | Publix Super Markets INC | 56062-312 |
| Tiger Supply Inc Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Tiger Supply Inc. | 69484-001 |
| Oral Anesthetic Liquidbenzocaine | Benzocaine 20 g/100g | LiquidOral | Meijer, Inc. | 79481-0118 |
| Sensodyne Pronamel Clinical Enamel Strength Whitening Actionpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0811 |
| Sensodyne Clinical White Intensive Cleanpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-5468 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-133 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | SprayDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0914 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
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