NDC codes

FDA NDC Directory
Product NDC (as listed)35000-998Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35000-0998Add 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
35000-998-6035000099860350000998601 TUBE in 1 CARTON (35000-998-60) / 85 g in 1 TUBEMarketed from Nov 1, 2022
35000-998-7135000099871350000998711 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBEMarketed from Nov 1, 2022

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)
sodium fluoride
Active ingredients
Sodium fluoride — 1.5 mg/gPotassium nitrate — 50 mg/g
Dosage form
Paste, Dentifrice
Route
Dental
Labeler
Colgate-Palmolive CompanyNDC labeler code 35000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Marketing end
Identifiers
Product ID 35000-998_53744624-454a-4b7a-b87b-08ea33e238aaSPL ID 53744624-454a-4b7a-b87b-08ea33e238aaSPL set ID 6ec2fff7-df44-4302-be2d-97946c6cd66aRxCUI 1038929UNII 8ZYQ1474W7, RU45X2JN0Z

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N435000099860 followed by a unit qualifier and the quantity

Package 35000-0998-60. 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)

Use helps protect against cavities

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35000-998

What is NDC 35000-998?
35000-998 is the product NDC for Colgate Optic White Stain Fighter Sens Relief, Sodium fluoride 1.5 mg/g; Potassium nitrate 50 mg/g paste, dentifrice, listed with the FDA by Colgate-Palmolive Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Colgate Optic White Stain Fighter Sens Relief (Sodium fluoride).
What is the active ingredient?
Sodium fluoride, Potassium nitrate.
Who is the labeler?
Colgate-Palmolive Company, NDC labeler code 35000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Colgate Optic White Stain Fighter Sens Relief?
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
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-1820
Organic Peppermint Herb Throat DropsmentholMenthol 1.9 mg/1LozengeOralRicola USA Inc.63667-010
Equate Sculpted White TP Equate Sculpted White TPsodium fluorideSodium fluoride .15 g/100gPaste, DentifriceOralWalmart79903-282
Ki No Sincalcium carbonateCalcium carbonate 55 mg/500mgTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-322
R B onephosphatidylserine, zinc oxideZinc oxide 6.38 mg/1100mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-140
Sensodynepotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0550
parodontaxstannous fluorideStannous fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0598
CVS Health Sensitive Enamel Repairsodium fluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceOralCVS51316-169
Alzh Lphosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-230
TopicalebenzocaineBenzocaine 180 mg/gOintmentOralMedical Products Laboratories, Inc.10733-162
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gPaste, DentifriceTopicalWalgreens0363-5337
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralWalgreens0363-5820
Dem Zerophosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-240
Benzoin Tincturebenzoin resinBenzoin resin 1000 mg/mLLiquidTopical11695664470677-1200
Rite Aid Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-0345
Chloraseptic Sore Throat CitrusphenolPhenol 1.4 g/100mLSprayOralPrestige Brands Holdings, Inc.67172-112
Sore Throat Relief Cherry FlavorphenolPhenol 1.4 g/100mLSprayOralCardinal Health70000-0458
HurriCaine Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0293
Rite Aid Professional StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-5340
Benzocaine 20%Benzocaine 200 mg/mLSolutionTopicalPAI Holdings, LLC dba PAI Pharma0121-1077

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