Over-the-counter drug · OTC MONOGRAPH DRUG
4X Medicated Toothache and Gum Gel (Benzocaine) NDC 49035-569
Benzocaine 20 g/100g + 3 more ingredients · Gel · Oral · Walmart
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-569-99 | 4903505699949035056999 | 1 g in 1 TUBE (49035-569-99)Marketed from May 18, 2020 |
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)
- 4X Medicated Toothache and Gum Gel
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 20 g/100gZinc chloride — .15 g/100gBenzalkonium chloride — .13 g/100gMenthol — .5 g/100g
- Dosage form
- Gel
- Route
- Oral
- Labeler
- WalmartNDC labeler code 49035
- 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)Decreased Copper Ion Absorption (Physiologic effect)Increased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 49035-569_437fd35c-d085-cbb8-e063-6394a90a1c11SPL ID 437fd35c-d085-cbb8-e063-6394a90a1c11SPL set ID a471a858-edbf-c31e-e053-2995a90a7156RxCUI 2369638UNII U3RSY48JW5, 86Q357L16B, F5UM2KM3W7, L7T10EIP3A
- Pharmacologic class
- Copper Absorption Inhibitor; 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
N449035056999followed by a unit qualifier and the quantityPackage 49035-0569-99. 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)
Directions Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in teh use of this product * children under 2 years of age: do not use
Excerpt only. Read the full label for complete information.
About NDC 49035-569
- What is NDC 49035-569?
- 49035-569 is the product NDC for 4X Medicated Toothache and Gum Gel, Benzocaine 20 g/100g + 3 more ingredients gel, listed with the FDA by Walmart. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 4X Medicated Toothache and Gum Gel (Benzocaine).
- What is the active ingredient?
- Benzocaine, Zinc chloride, Benzalkonium chloride, Menthol.
- Who is the labeler?
- Walmart, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 4X Medicated Toothache and Gum Gel?
- 3 other product NDCs are listed under this name. See all 4X Medicated Toothache and Gum Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 4X Medicated Toothache and Gum Gel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | Gel, DentifriceOral | Publix Super Markets INC | 56062-312 | 56062-0312-22 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 | 69842-0642-29 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Menthol, Unspecified form .5 g/100g + 3 more ingredients | GelOral | Walgreens | 0363-6008 | 00363-6008-89 |
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 | 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 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-101 |
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