NDC codes

FDA NDC Directory
Product NDC (as listed)35000-196Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35000-0196Add 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
35000-196-443500001964435000019644124 g in 1 BOTTLE, PUMP (35000-196-44)Marketed from May 5, 2020

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

Brand name (proprietary)
Colgate Maximum Cavity Protection Bubble Fruit FlavorSuffix: Bubble Fruit Flavor
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1.1 mg/g
Dosage form
Gel, Dentifrice
Route
Dental
Labeler
Colgate-Palmolive CompanyNDC labeler code 35000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Marketing end
Identifiers
Product ID 35000-196_05db5425-ea54-45c0-a50e-2d1d08fa8853SPL ID 05db5425-ea54-45c0-a50e-2d1d08fa8853SPL set ID 0a1389f6-cac9-3d58-0744-c488abb0bbccRxCUI 416783UNII 8ZYQ1474W7

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

N435000019644 followed by a unit qualifier and the quantity

Package 35000-0196-44. 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 35000-196

What is NDC 35000-196?
35000-196 is the product NDC for Colgate Maximum Cavity Protection Bubble Fruit Flavor, Sodium fluoride 1.1 mg/g gel, dentifrice, listed with the FDA by Colgate-Palmolive Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Colgate Maximum Cavity Protection Bubble Fruit Flavor (Sodium fluoride).
What is the active ingredient?
Sodium fluoride.
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 Maximum Cavity Protection Bubble Fruit Flavor?
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 021

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 021
ProductStrengthForm · routeLabelerProduct NDC
Colgate Strawberry Burstsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-915
Toms Of Maine Whiten Plus Deep Clean Spearmintsodium fluorideSodium fluoride 1.1 mg/gPaste, DentifriceDentalTom's of Maine, Inc.51009-921
Freshen Upsodium fluorideSodium fluoride 24 mg/100gGel, DentifriceDentalMKJ BRANDS LLC77782-015
Alcohol-Free Anticavitysodium fluorideSodium fluoride .1 mg/mLLiquidOralWalmart Inc.79903-279
Crest 3D White Fresh Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manufactura, S. de R.L. de C.V.58933-881
Colgate Sparkling White Cinnamintsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-900
Toms Of Maine Wicked Cool Mild Mintsodium monofluorophosphateSodium monofluorophosphate 1 mg/gPaste, DentifriceDentalTom's of Maine, Inc.51009-912
DG health Sensitive Maximum Strengthpotassium nitrate, sodium fluorideSodium fluoride .24 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceDentalDolgencorp, LLC55910-360
GuruNanda Anticavitysodium fluorideSodium fluoride .2 mg/mLMouthwashOralGURUNANDA, LLC70708-927
Equate Optimal Care TP Equate Optimal Care TPstannous fluorideStannous fluoride .16 g/100gPaste, DentifriceOralWalmart Inc.79903-280
Crest 3D White Stain Eraser Icy Clean Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.58933-932
Colgate Max Fresh Cool Mintsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-903
Toms of Maine Whiten Plus Deep Clean Peppermintsodium fluorideSodium fluoride 1.1 mg/gPaste, DentifriceDentalTom's of Maine51009-920
Equate Pro-Advanced TP Equate Pro-Advanced TPstannous fluorideStannous fluoride .16 g/100gPaste, DentifriceOralWalmart Inc.79903-281
COLGATE Great Regular Flavorsodium monofluorophosphateSodium monofluorophosphate 1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-913
Crest Complete plus Whiteningsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company69423-894
Eversmile OrthoFoam Anticavity0.05% sodium fluoride rinseSodium fluoride .05 g/100mLLiquidDentalEverbrands, Inc.72655-600
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company84126-662
Therabreath Healthy Gumsstannous fluorideStannous fluoride .454 g/100gPaste, DentifriceOralChurch & Dwight Co., Inc.10237-271
Crest 3D White Brilliance Charcoalsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manfuacturing Company37000-989

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