Over-the-counter drug · OTC MONOGRAPH DRUG
Topicale (Benzocaine) NDC 10733-167
Benzocaine 180 mg/g · Gel · Oral · Medical Products Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10733-167-43 | 10733016743 | 43 g in 1 BOTTLE, PUMP (10733-167-43)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 10733-167_28dd17ff-9097-d336-e063-6394a90a00fdSPL ID 28dd17ff-9097-d336-e063-6394a90a00fdSPL set ID 8281700c-10f9-841c-e053-2991aa0a918fRxCUI 1042838, 1049213UNII 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
N410733016743followed by a unit qualifier and the quantityPackage 10733-0167-43. 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 10733-167
- What is NDC 10733-167?
- 10733-167 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 | 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 |
| 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 |
|---|---|---|---|---|
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavityfluoride | Fluoride ion .1 mg/mL | MouthwashOral | WHOLE FOODS | 42681-0048 |
| 3ECARE Dual formula WhiteningToothpaste Refillsodium fluoride | Sodium fluoride .155 g/100g | OintmentSubgingival | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-002 |
| 3x Medicated Mouth Sore Gelbenzocaine | Zinc chloride .15 g/100g + 2 more ingredients | GelOral | Walgreens | 0363-1605 |
| 3X Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-6170 |
| 3x Medicated Mouth Sore Gelbenzocaine | Menthol, Unspecified form .1 g/100g + 2 more ingredients | GelOral | HEB | 37808-691 |
| 3x Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-660 |
| 3x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-693 |
| 4-in-1 Teeth Care Pens | Sodium fluoride .25 g/100g | Gel, DentifriceTopical | Jiangxi Dentalbright Technology Co., Ltd | 83778-011 |
| 4X Medicated Severe Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | Rite Aid | 11822-0614 |
| 4X Medicated Severe Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | Rite Aid | 11822-0615 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | HEB | 37808-116 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | CreamOral | CVS | 69842-631 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Menthol, Unspecified form .5 g/100g + 3 more ingredients | GelOral | Walgreens | 0363-6008 |
| 4X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | GelOral | Walmart | 49035-569 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | Gel, DentifriceOral | Publix Super Markets INC | 56062-312 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 |
| 7 Select Oral Pain Maximum Strength Reliefbenzocaine | Benzocaine 200 mg/g | GelTopical | 7-ELEVEN, INC. | 10202-853 |
| ABC Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | AMERISOURCE BERGEN | 46122-749 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4860 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-100 |
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