NDC codes

FDA NDC Directory
Product NDC (as listed)35000-683Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35000-0683Add 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
35000-683-103500006831035000068310473 mL in 1 BOTTLE (35000-683-10)Marketed from Jul 1, 2023

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)
Hello Peace Out Plaque peace out, plaque antigingivitisSuffix: peace out, plaque antigingivitis
Generic name (nonproprietary)
cetylpyridinium chloride
Active ingredients
Cetylpyridinium chloride — 15 mg/20mL
Dosage form
Mouthwash
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
Marketing end
Identifiers
Product ID 35000-683_1a456063-e89d-4697-8a54-54094a28696eSPL ID 1a456063-e89d-4697-8a54-54094a28696eSPL set ID a0fb33a6-621f-a972-2ff7-1bb899f27f3bRxCUI 1599135UNII 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

N435000068310 followed by a unit qualifier and the quantity

Package 35000-0683-10. 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)

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 35000-683

What is NDC 35000-683?
35000-683 is the product NDC for Hello Peace Out Plaque peace out, plaque antigingivitis, Cetylpyridinium chloride 15 mg/20mL mouthwash, 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?
Hello Peace Out Plaque peace out, plaque antigingivitis (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 Hello Peace Out Plaque peace out, plaque antigingivitis?
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)
ProductStrengthForm · routeLabelerProduct NDC
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizeralcoholAlcohol 70 mL/100mLSprayTopicalChurch & Dwight Co., Inc.10237-117
DrugStore Antibacterial Hand Wipesbenzalkonium chlorideBenzalkonium chloride .13 g/100gClothTopicalLil' Drug Store Products, Inc.29485-6666
EcolabalcoholAlcohol 62 mL/100mLSolutionTopicalEcolab Inc.47593-472
Covex Antibacterial Bar Fresh Protectionbenzalkonium chlorideBenzalkonium chloride 1.3 mg/gSoapTopicalDALAN KIMYA ENDUSTRI ANONIM SIRKETI51209-020
Anti Bacterial Hand Gel Cookie Butter TrufflealcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6759
Anti Bacterial Hand Gel Strawberry KiwialcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7020
Hyvee LHSbwenzalkonium chlorideBenzalkonium chloride 130 mg/100mLLiquidTopicalApollo Health and Beauty Care63148-326
Benzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalPharmacy Value Alliance, LLC68016-866
Lavender ALOE HAND SANITIZERalcoholAlcohol .62 mL/mLGelTopicalK7 Design Group Inc.74177-025
hair treatmentminoxidilMinoxidil 1 mg/473mLCreamTopicalLABORATORIO MK SRL87022-009
SoftSoap Antibacterial with moisturizers Fresh Citrusbenzalkonium chlorideBenzalkonium chloride 1.33 mg/mLLiquidTopicalColgate-Palmolive Company35000-087
MediChoice PVP Prep Solutionpovidone-iodinePovidone-iodine 100 mg/mLSolutionTopicalO&M HALYARD, INC.39892-0841
Tartar control pluseucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralUnited Natural Foods, Inc. dba UNFI41163-855
Covex Antibacterial Bar Active Protectionbenzalkonium chlorideBenzalkonium chloride 1.3 mg/gSoapTopicalDALAN KIMYA ENDUSTRI ANONIM SIRKETI51209-017
everyone hand sanitizer wipes ruby grapefruitethyl alcoholAlcohol 62 mL/100mLClothTopicalEO Products, LLC54748-703
Povidone-Iodine Prep Sterilepovidone-iodinePovidone-iodine 100 mg/gSpongeTopicalChangzhou Maokang Medical Products Co., Ltd59050-658
Anti Bacterial Hand Gel Bright Christmas MorningalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6758
Iced Lemon Pound Cake Pistachio Milk and HoneyalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7018
Hy-Vee LHSbenzalkonium chlorideBenzalkonium chloride 130 mg/100mLLiquidTopicalApollo Health and Beauty Care63148-316
Smart Care 2 HAND SANITIZERS 1.35 FL OZ (PUMPKIN SPICE, FRESH RAIN)ethyl alcohol—KitAshtel Studios, Inc.70108-372

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