Over-the-counter drug · OTC MONOGRAPH DRUG

Antibacterial (Chloroxylenol) NDC 0404-4441

Chloroxylenol 6.046 g/L · Liquid · Topical · Henry Schein, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0404-4441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-4441Add 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
0404-4441-010040444410100404444101.55 L in 1 BOTTLE (0404-4441-01)Marketed from Jan 31, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Antibacterial
Generic name (nonproprietary)
chloroxylenol
Active ingredients
Chloroxylenol — 6.046 g/L
Dosage form
Liquid
Route
Topical
Labeler
Henry Schein, Inc.NDC labeler code 0404
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 0404-4441_2b5c5b12-5a09-b779-e063-6394a90a5238SPL ID 2b5c5b12-5a09-b779-e063-6394a90a5238SPL set ID 22a162f7-4408-47c1-a792-a6fbdabdb331RxCUI 413262UNII 0F32U78V2Q

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

N400404444101 followed by a unit qualifier and the quantity

Package 00404-4441-01. 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 For handwashing to decrease bacteria on skin. Recommended for repeated use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-4441

What is NDC 0404-4441?
0404-4441 is the product NDC for Antibacterial (chloroxylenol), Chloroxylenol 6.046 g/L liquid, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Antibacterial (Chloroxylenol).
What is the active ingredient?
Chloroxylenol.
Who is the labeler?
Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Antibacterial?
14 other product NDCs are listed under this name. See all Antibacterial NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Antibacterial NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalTopco Associates LLC76162-27976162-0279-0376162-0279-96
Antibacterialbenzalkonium chloride soapBenzalkonium chloride 1.3 mg/mLLiquidTopicalTopco Associates LLC76162-89776162-0897-0376162-0897-96
Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLSoapTopicalOld East Main Co.75712-89775712-0897-0375712-0897-96
AntibacterialchloroxylenolChloroxylenol .01 mg/mLGelTopicalCustom Chemical Solutions77955-00477955-0004-02
AntibacterialalcoholAlcohol 665 mL/LLiquidTopicalHenry Schein Inc.0404-012200404-0122-02
Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLSoapTopicalMeijer, Inc.41250-97641250-0976-03
Antibacterialbenzethonium chlorideBenzethonium chloride .13 g/100mLLiquidTopicalMcKesson68599-550168599-5501-0168599-5501-0268599-5501-03+1 more
Antibacterialbenzethonium chlorideBenzethonium chloride .13 g/100mLLiquidTopicalMcKesson68599-550268599-5502-0168599-5502-0268599-5502-03
Antibacterialbenzalkonium chlorideBenzalkonium chloride 13 mg/10mLSoapTopicalRubbermaid Commercial Products LLC65321-03165321-0031-0165321-0031-02
Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalSante Manufacturing Inc71020-00171020-0001-1671020-0001-20

All 15 Antibacterial NDCs

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

Showing 20 of 40.

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