What is NDC 35000-281?

35000-281 is the product NDC for Colgate Total Active Prevention Gum Health, Cetylpyridinium chloride 15 mg/20mL rinse, 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 Total Active Prevention Gum Health (Cetylpyridinium chloride).

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 Total Active Prevention Gum Health?

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.

NDC 35000-281

NDC codes

FDA NDC Directory

Product NDC (as listed)35000-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35000-0281Add 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 NDC	11-digit (billing)	Package	Copy
35000-281-16	3500002811635000028116	500 mL in 1 BOTTLE (35000-281-16)Marketed from Oct 31, 2024
35000-281-31	3500002813135000028131	1000 mL in 1 BOTTLE (35000-281-31)Marketed from Oct 31, 2024

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 Total Active Prevention Gum Health
Generic name (nonproprietary): cetylpyridinium chloride
Active ingredients: Cetylpyridinium chloride — 15 mg/20mL
Dosage form: Rinse
Route: Dental
Labeler: Colgate-Palmolive CompanyNDC labeler code 35000
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication 505G(a)(3)
Marketing start: Oct 31, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 35000-281_1fd3db84-50ed-40bd-b913-8dea8203c96eSPL ID 1fd3db84-50ed-40bd-b913-8dea8203c96eSPL set ID fb63b8bb-826a-42e6-a429-b8d86c5c9223RxCUI 1599135, 1599137UNII D9OM4SK49P

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

N435000028116 followed by a unit qualifier and the quantity

Package 35000-0281-16. 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 Oct 4, 2024.

Indications (excerpt from the label)

Uses helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35000-281

What is NDC 35000-281?: 35000-281 is the product NDC for Colgate Total Active Prevention Gum Health, Cetylpyridinium chloride 15 mg/20mL rinse, 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 Total Active Prevention Gum Health (Cetylpyridinium chloride).
What is the active ingredient?: Cetylpyridinium chloride.
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 Total Active Prevention Gum Health?: 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 505G(a)(3)

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

FDA NDC Directory listings under 505G(a)(3)
Product	Strength	Form · route	Labeler	Product NDC
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizeralcohol	Alcohol 70 mL/100mL	SprayTopical	Church & Dwight Co., Inc.	10237-117
DrugStore Antibacterial Hand Wipesbenzalkonium chloride	Benzalkonium chloride .13 g/100g	ClothTopical	Lil' Drug Store Products, Inc.	29485-6666
Ecolabalcohol	Alcohol 62 mL/100mL	SolutionTopical	Ecolab Inc.	47593-472
Covex Antibacterial Bar Fresh Protectionbenzalkonium chloride	Benzalkonium chloride 1.3 mg/g	SoapTopical	DALAN KIMYA ENDUSTRI ANONIM SIRKETI	51209-020
Anti Bacterial Hand Gel Cookie Butter Trufflealcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6759
Anti Bacterial Hand Gel Strawberry Kiwialcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-7020
Hyvee LHSbwenzalkonium chloride	Benzalkonium chloride 130 mg/100mL	LiquidTopical	Apollo Health and Beauty Care	63148-326
Benzalkonium chloride	Benzalkonium chloride 1.3 mg/mL	LiquidTopical	Pharmacy Value Alliance, LLC	68016-866
Lavender ALOE HAND SANITIZERalcohol	Alcohol .62 mL/mL	GelTopical	K7 Design Group Inc.	74177-025
hair treatmentminoxidil	Minoxidil 1 mg/473mL	CreamTopical	LABORATORIO MK SRL	87022-009
SoftSoap Antibacterial with moisturizers Fresh Citrusbenzalkonium chloride	Benzalkonium chloride 1.33 mg/mL	LiquidTopical	Colgate-Palmolive Company	35000-087
MediChoice PVP Prep Solutionpovidone-iodine	Povidone-iodine 100 mg/mL	SolutionTopical	O&M HALYARD, INC.	39892-0841
Tartar control pluseucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	United Natural Foods, Inc. dba UNFI	41163-855
Covex Antibacterial Bar Active Protectionbenzalkonium chloride	Benzalkonium chloride 1.3 mg/g	SoapTopical	DALAN KIMYA ENDUSTRI ANONIM SIRKETI	51209-017
everyone hand sanitizer wipes ruby grapefruitethyl alcohol	Alcohol 62 mL/100mL	ClothTopical	EO Products, LLC	54748-703
Povidone-Iodine Prep Sterilepovidone-iodine	Povidone-iodine 100 mg/g	SpongeTopical	Changzhou Maokang Medical Products Co., Ltd	59050-658
Anti Bacterial Hand Gel Bright Christmas Morningalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6758
Iced Lemon Pound Cake Pistachio Milk and Honeyalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-7018
Hy-Vee LHSbenzalkonium chloride	Benzalkonium chloride 130 mg/100mL	LiquidTopical	Apollo Health and Beauty Care	63148-316
Smart Care 2 HAND SANITIZERS 1.35 FL OZ (PUMPKIN SPICE, FRESH RAIN)ethyl alcohol	—	Kit	Ashtel Studios, Inc.	70108-372

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Colgate Total Active Prevention Gum Health (Cetylpyridinium chloride) NDC 35000-281