Over-the-counter drug · OTC MONOGRAPH DRUG
4X Medicated Severe Toothache and Gum Gel (Benzocaine) NDC 11822-0615
Benzalkonium chloride .13 g/100g + 3 more ingredients · Gel · Oral · Rite Aid
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0615-9 | 11822061509 | 1 TUBE in 1 CARTON (11822-0615-9) / 7 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 Gel
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzalkonium chloride — .13 g/100gZinc chloride — .15 g/100gMenthol — .5 g/100gBenzocaine — 20 g/100g
- Dosage form
- Gel
- 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 11822-0615_437ffe13-51f2-ebce-e063-6394a90a0185SPL ID 437ffe13-51f2-ebce-e063-6394a90a0185SPL set ID 99703bf4-f169-5e05-e053-2995a90afab4RxCUI 2369638UNII F5UM2KM3W7, 86Q357L16B, L7T10EIP3A, U3RSY48JW5
- 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
N411822061509followed by a unit qualifier and the quantityPackage 11822-0615-09. 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 ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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 lightneadedness * 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 mor…
Excerpt only. Read the full label for complete information.
About NDC 11822-0615
- What is NDC 11822-0615?
- 11822-0615 is the product NDC for 4X Medicated Severe Toothache and Gum Gel, Benzalkonium chloride .13 g/100g + 3 more ingredients gel, 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 Gel (Benzocaine).
- What is the active ingredient?
- Benzalkonium chloride, Zinc chloride, Menthol, Benzocaine.
- 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 Gel?
- 1 other product NDC are listed under this name. See all 4X Medicated Severe 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 Severe 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 Severe Toothache and Gum Gelbenzalkonium chloride | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | Meijer | 79481-0610 | 79481-0610-09 |
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 |
|---|---|---|---|---|
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2903 |
| LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Kenvue Brands LLC | 69968-0400 |
| Lolleez Watermelonpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3295 |
| meijer Sensitive FRESH MINTpotassium nitrate, sodium fluoride | Potassium nitrate 5 g/100g; Sodium fluoride .24 g/100g | Paste, DentifriceDental | Meijer, Inc. | 79481-0039 |
| parodontax Active Gum Repair Whiteningstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0638 |
| Opalescence Sensitivity Relief Whiteningpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-308 |
| Sensitivity Relief Fluoride Freepotassium nitrate | Potassium nitrate 50 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2105 |
| Sucrets Sore Throat Wild Cherrydyclonine hydrochloride | Dyclonine hydrochloride 2 mg/1 | LozengeOral | Insight Pharmaceuticals LLC | 63736-560 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-356 |
| Lemon Glyceringlycerin | Glycerin .3 g/4g | SwabOral | Dynarex Corporation | 67777-161 |
| Anesgerm LA MUELA Fast Pain Reliefbenzocaine 20% | Benzocaine 200 mg/mL | LiquidTopical | Germa Products, LLC | 73635-7101 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Extra Freshpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0486 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Opal by Opalescence Sensitivitypotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-311 |
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2901 |
| Sensitivity and Gum with Cavity Protectionpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 7.6 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2210 |
| Sucretsdyclonine hcl, menthol, and pectin | Dyclonine hydrochloride 2 mg/1 + 2 more ingredients | LozengeOral | Insight Pharmaceuticals LLC | 63736-567 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-357 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 150 mg/10mL | MouthwashTopical | CVS Pharmacy, Inc. | 69842-008 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
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