Over-the-counter drug · OTC MONOGRAPH DRUG
4X Medicated Severe Toothache and Gum Cream (Benzocaine) NDC 11822-0614
Benzocaine 20 g/100g + 3 more ingredients · Cream · Oral · Rite Aid
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0614-9 | 11822061409 | 1 TUBE in 1 CARTON (11822-0614-9) / 9.4 g in 1 TUBEMarketed from May 6, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Severe Toothache and Gum Cream
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 20 g/100gMenthol — .26 g/100gZinc chloride — .15 g/100gBenzalkonium chloride — .13 g/100g
- Dosage form
- Cream
- Route
- Oral
- Labeler
- Rite AidNDC labeler code 11822
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Marketing end
- 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 11822-0614_437ff1ad-5461-e55c-e063-6394a90a258bSPL ID 437ff1ad-5461-e55c-e063-6394a90a258bSPL set ID 996fdbeb-1fe3-77b6-e053-2995a90a25c7RxCUI 2370903UNII U3RSY48JW5, L7T10EIP3A, 86Q357L16B, F5UM2KM3W7
- 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
N411822061409followed by a unit qualifier and the quantityPackage 11822-0614-09. 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)
Warnings Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy Allergy alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics Do not use * more than directed * for more …
Excerpt only. Read the full label for complete information.
About NDC 11822-0614
- What is NDC 11822-0614?
- 11822-0614 is the product NDC for 4X Medicated Severe Toothache and Gum Cream, Benzocaine 20 g/100g + 3 more ingredients cream, listed with the FDA by Rite Aid. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 4X Medicated Severe Toothache and Gum Cream (Benzocaine).
- What is the active ingredient?
- Benzocaine, Menthol, Zinc chloride, Benzalkonium chloride.
- Who is the labeler?
- Rite Aid, NDC labeler code 11822. 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 Severe Toothache and Gum Cream?
- 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 |
|---|---|---|---|---|
| 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 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0520 |
| HurriCaine Topical Anesthetic Liquidbenzocaine | Benzocaine 200 mg/g | LiquidDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1116 |
| Orajel Rescue Relief Penoral pain reliever | Zinc chloride 1.5 mg/g + 2 more ingredients | GelOral | Church & Dwight Co., Inc. | 10237-731 |
| Sensodyne Complete Protectionstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0573 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | HEB | 37808-116 |
| Gumsolbenzocaine, zinc chloride | Benzocaine 1.5 g/30mL; Zinc chloride .03 g/30mL | SprayOral | Kramer Novis | 52083-714 |
| Oral Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | GERI-CARE PHARMACEUTICAL CORP | 57896-139 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | CreamOral | CVS | 69842-631 |
| Mouthwashmenthol, methyl salicylate, thymol | Methyl salicylate .6 mg/mL + 3 more ingredients | LiquidOral | Orazen Inc | 71927-006 |
| Made by Dentists Enamel Rebuilding Fresh Mintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-028 |
| Made by Dentists Sensitive and Whitening Fresh Mintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-029 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Ear Wax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidAuricular (Otic) | BETTER LIVING BRANDS, LLC | 21130-793 |
| Sore Throat Relief Cherryphenol | Phenol 1.4 g/100mL | SprayOral | Best Choice (Valu Merchandisers Company) | 63941-376 |
| Antiseptic Lil Drug Store Productseucalyptol, menthol, unspecified form, methyl salicylate, and thymol | Eucalyptol .92 mg/mL + 3 more ingredients | LiquidOral | Lil' Drug Store Products, Inc | 66715-6861 |
| Benzo-Jelbenzocaine | Benzocaine 200 mg/g | GelDental | Henry Schein Inc. | 0404-0033 |
| Kroger Enamel Protection Sensitive Gentle Whiteningpotassium nitrate, sodium fluoride | Potassium nitrate 5 g/100g; Sodium fluoride .15 g/100g | Paste, DentifriceDental | Kroger Company | 30142-362 |
| equate Sensitivepotassium nitrate, sodium fluoride | Potassium nitrate 5 g/100g; Sodium fluoride .15 g/100g | Paste, DentifriceDental | Wal-Mart Stores Inc | 49035-257 |
| LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Kenvue Brands LLC | 69968-0400 |
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