Over-the-counter drug · OTC MONOGRAPH DRUG
TopCare Oral Pain Relief Maximum Strength (Benzocaine) NDC 36800-512
Benzocaine 20 g/100g · Gel · Topical · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-512-29 | 36800051229 | 1 TUBE in 1 CARTON (36800-512-29) / 14 g in 1 TUBEMarketed 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)
- TopCare Oral Pain Relief Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 20 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-512_437fcc59-02bc-7d8c-e063-6394a90af1c0SPL ID 437fcc59-02bc-7d8c-e063-6394a90af1c0SPL set ID 835fb6ac-dbb7-5566-e053-2991aa0af5e2RxCUI 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N436800051229followed by a unit qualifier and the quantityPackage 36800-0512-29. 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 the temporary relief of pain due to toothaches
Excerpt only. Read the full label for complete information.
About NDC 36800-512
- What is NDC 36800-512?
- 36800-512 is the product NDC for TopCare Oral Pain Relief Maximum Strength, Benzocaine 20 g/100g gel, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Oral Pain Relief Maximum Strength (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare Oral Pain Relief Maximum Strength?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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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