NDC codes

FDA NDC Directory
Product NDC (as listed)11822-0614Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0614Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
11822-0614-9118220614091 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

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

N411822061409 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 022
ProductStrengthForm · routeLabelerProduct NDC
Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and mentholBenzocaine 15 mg/1; Menthol 20 mg/1LozengeOralThe Procter & Gamble Manufacturing Company84126-366
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0520
HurriCaine Topical Anesthetic LiquidbenzocaineBenzocaine 200 mg/gLiquidDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-1116
Orajel Rescue Relief Penoral pain relieverZinc chloride 1.5 mg/g + 2 more ingredientsGelOralChurch & Dwight Co., Inc.10237-731
Sensodyne Complete Protectionstannous fluorideStannous fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0573
4x Medicated Toothache and Gum CreambenzocaineBenzocaine 20 g/100g + 3 more ingredientsCreamOralHEB37808-116
Gumsolbenzocaine, zinc chlorideBenzocaine 1.5 g/30mL; Zinc chloride .03 g/30mLSprayOralKramer Novis52083-714
Oral Pain ReliefbenzocaineBenzocaine 200 mg/gGelOralGERI-CARE PHARMACEUTICAL CORP57896-139
4x Medicated Toothache and Gum CreambenzocaineBenzalkonium chloride .13 g/100g + 3 more ingredientsCreamOralCVS69842-631
Mouthwashmenthol, methyl salicylate, thymolMethyl salicylate .6 mg/mL + 3 more ingredientsLiquidOralOrazen Inc71927-006
Made by Dentists Enamel Rebuilding Fresh Mintpotassium nitrate, sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/gPasteDentalMADE BY DENTISTS INC75065-028
Made by Dentists Sensitive and Whitening Fresh Mintpotassium nitrate, sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/gPasteDentalMADE BY DENTISTS INC75065-029
UltraCare Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Periodontal, TopicalThe Bellport Company, Inc. dba Gingi-Pak10129-071
Ear Wax Removal Aid Dropscarbamide peroxideCarbamide peroxide 65 mg/mLLiquidAuricular (Otic)BETTER LIVING BRANDS, LLC21130-793
Sore Throat Relief CherryphenolPhenol 1.4 g/100mLSprayOralBest Choice (Valu Merchandisers Company)63941-376
Antiseptic Lil Drug Store Productseucalyptol, menthol, unspecified form, methyl salicylate, and thymolEucalyptol .92 mg/mL + 3 more ingredientsLiquidOralLil' Drug Store Products, Inc66715-6861
Benzo-JelbenzocaineBenzocaine 200 mg/gGelDentalHenry Schein Inc.0404-0033
Kroger Enamel Protection Sensitive Gentle Whiteningpotassium nitrate, sodium fluoridePotassium nitrate 5 g/100g; Sodium fluoride .15 g/100gPaste, DentifriceDentalKroger Company30142-362
equate Sensitivepotassium nitrate, sodium fluoridePotassium nitrate 5 g/100g; Sodium fluoride .15 g/100gPaste, DentifriceDentalWal-Mart Stores Inc49035-257
LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralKenvue Brands LLC69968-0400

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