Over-the-counter drug · OTC MONOGRAPH DRUG

Antibacterial (Benzalkonium chloride) NDC 65321-031

Benzalkonium chloride 13 mg/10mL · Soap · Topical · Rubbermaid Commercial Products LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)65321-031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65321-0031Add 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
65321-031-0165321003101800 mL in 1 BOTTLE, PUMP (65321-031-01)Marketed from Jul 24, 2017
65321-031-02653210031021600 mL in 1 BOTTLE, PUMP (65321-031-02)Marketed from Jul 24, 2017

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)
Antibacterial
Generic name (nonproprietary)
benzalkonium chloride
Active ingredients
Benzalkonium chloride — 13 mg/10mL
Dosage form
Soap
Route
Topical
Labeler
Rubbermaid Commercial Products LLCNDC labeler code 65321
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 65321-031_dab4b4c1-bc8d-4552-8d19-f683087d00abSPL ID dab4b4c1-bc8d-4552-8d19-f683087d00abSPL set ID 6023285c-6b02-410e-9492-df0543279f25RxCUI 1046593UNII F5UM2KM3W7UPC 0086876238969

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

N465321003101 followed by a unit qualifier and the quantity

Package 65321-0031-01. 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)

Use For hand washing to decrease bacteria on skin. Repeat as needed.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65321-031

What is NDC 65321-031?
65321-031 is the product NDC for Antibacterial (benzalkonium chloride), Benzalkonium chloride 13 mg/10mL soap, listed with the FDA by Rubbermaid Commercial Products LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Antibacterial (Benzalkonium Chloride).
What is the active ingredient?
Benzalkonium chloride.
Who is the labeler?
Rubbermaid Commercial Products LLC, NDC labeler code 65321. 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 1.3 mg/mLLiquidTopicalSante Manufacturing Inc71020-00171020-0001-1671020-0001-20
Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalSante Manufcaturing Inc71020-00371020-0003-32

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
JuniperCleanDishSoap Appledishwashing detergentChloroxylenol .2 g/100gLiquidCutaneous, TopicalKYNC DESIGN LLC76557-013
NatureWell Hydrating Hand Sanitizer Fresh SqueezealcoholAlcohol 70 mL/100mLLiquidTopicalAmerican Exchange Group78870-008
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-199
Arthcal 4% Lidocaine Gel PatcheslidocaineLidocaine 4 g/100gPatchExtracorporealBeijing JUNGE Technology Co., Ltd.85212-0005
PUTRIZEN ARNICA BRUISE RELIEF CreamArnica montana 15 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-028
VQ Hand Sanitizer Passion FloweralcoholAlcohol 70 mL/100mLLiquidTopicalTychea Co.85980-040
Advanced Hand Sanitizerethyl alcoholAlcohol 70 mL/100mLGelTopicalTopco Associates LLC36800-898
Alcohol Free Hand Sanitizerbenzalkonium chlorideBenzalkonium chloride 1 mg/mLAerosol, FoamTopicalFULLER INDUSTRIES, INC60933-200
CSI E3 Hand SanitizeralcoholAlcohol 70 mL/100mLLiquidTopicalCentral Solutions Inc62654-139
Anti Bacterial Hand Gel Fresh Amalfi LemonalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6837
Antispeticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralLidl US, LLC71141-156
GoodEarth Sanitizing Wipesbenzalkonium chlorideBenzalkonium chloride 3.822 mg/1ClothTopicalGoodEarth Distribution LLC71745-003
Juniper Clean Hand SanitizeralcoholAlcohol 70 mL/100mLGelTopicalKYNC Design LLC76557-000
QIDILA 5% Minoxidil Foamminoxidil,biotinMinoxidil 5 g/100mL; Biotin 5 g/100mLAerosol, FoamExtracorporealBeijing JUNGE Technology Co., Ltd.85212-0002
5% Menthol Pain Relief Patchpain relief patchMenthol 5 g/100gPatchTopicalXuzhou Lanting Pharmaceutical Co., Ltd85323-006
VQ Hand Sanitizer Citrus SplashalcoholAlcohol 70 mL/100mLLiquidTopicalTychea Co.85980-037
Lidocaine Pain Relief Gel -PatchlidocaineLidocaine .04 g/gPatchTopicalGuangzhou Sumi Technology Innovation Co., Ltd87518-185
Ormadus Foodservice Antibacterial Foambenzalkonium chlorideBenzalkonium chloride .13 g/100mLLiquidTopicalSC Johnson Professional USA Inc11084-023
Antisepticcetylpyridinium chlorideCetylpyridinium chloride .7 mg/mLRinseOralTopco Associates LLC36800-299
EcoCare 350isopropyl alcoholIsopropyl alcohol 80 mL/100mLSolutionTopicalEcolab Inc.47593-363

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