NDC codes

FDA NDC Directory
Product NDC (as listed)63868-953Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0953Add 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
63868-953-1163868095311638680953111 TUBE in 1 CARTON (63868-953-11) / 11.76 g in 1 TUBEMarketed from May 31, 2013

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

Generic name (nonproprietary)
benzocaine
Active ingredients
Benzocaine — 20 g/100g
Dosage form
Gel
Route
Topical
Labeler
Chain Drug Marketing Association IncNDC labeler code 63868
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 63868-953_41629205-ee47-326e-e063-6294a90ab1ecSPL ID 41629205-ee47-326e-e063-6294a90ab1ecSPL set ID dbde8e7f-85d8-4083-b01a-3a7e410a7747RxCUI 238910UNII U3RSY48JW5UPC 0635515953628
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

N463868095311 followed by a unit qualifier and the quantity

Package 63868-0953-11. 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 Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around 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 the use of this product. Children under 2 years of age. Do not use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63868-953

What is NDC 63868-953?
63868-953 is the product NDC for Quality Choice Maximum Strength Oral Pain Relieving, Benzocaine 20 g/100g gel, listed with the FDA by Chain Drug Marketing Association Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Quality Choice Maximum Strength Oral Pain Relieving (Benzocaine).
What is the active ingredient?
Benzocaine.
Who is the labeler?
Chain Drug Marketing Association Inc, NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Quality Choice Maximum Strength Oral Pain Relieving?
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
Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxideHydrogen peroxide 3 mL/100mLLiquidTopicalP & L Development, LLC49580-0268
SalinenasalSodium chloride 6.5 mg/mLSprayNasalBi-Mart37835-998
CVS Health Sensitive Enamel Repairsodium fluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceOralCVS51316-169
Ricola Max Nasal Care Cool MentholmentholMenthol 15.3 mg/1LozengeOralRicola Ag54305-206
Orajel Medicated for Toothache and Gum, Liquidbenzocaine and mentholBenzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mLLiquidTopicalChurch & Dwight Co., Inc.10237-796
Throat Balm Caramel PectinpectinPectin 3.8 mg/1LozengeOralRicola Ag54305-301
Throat Balm Caramel PectinpectinPectin 3.8 mg/1LozengeOralRicola USA Inc.63667-301
Hydrogen Peroxide 3 Percenthydrogen peroxideHydrogen peroxide 2.65 mL/100mLLiquidTopicalWhole Foods Market42681-6414
Sore throat cherryphenolPhenol 1.4 g/100mLSprayOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-376
Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chlorideCetylpyridinium chloride .07 g/mLRinseOralThe Procter & Gamble Manufacturing Company84126-648
Crest Kids Advanced Color Changingsodium monofluorophosphateSodium monofluorophosphate 1.6 mg/gPaste, DentifriceDentalProcter & Gamble Manufactura, S de R.L. de C.V.58933-012
Sootheez Berry LemonadepectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-4014
Sootheez Organic Wild CherrypectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-3714
Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1%Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/gGelTopicalQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)83324-035
Rite Aid Professional StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-5340
SENSODYNE Rapid Reliefstannous fluorideStannous fluoride 1.1 mg/gPasteOralHaleon US Holdings LLC0135-0622
Iodent Oral AnalgesicbenzocaineBenzocaine 200 mg/gGelTopicalUnited Exchange Corp.65923-094
Sootheez Organic Wild CherrypectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-3714
Topcare Sore Throat Menthol FlavorphenolPhenol 1.4 g/100mLSprayOralTOPCO ASSOCIATES LLC36800-606
Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/gPasteDentalHaleon US Holdings LLC0135-0580

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