NDC codes

FDA NDC Directory
Product NDC (as listed)50865-215Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50865-0215Add 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
50865-215-09508650215093785 mL in 1 BOTTLE, PLASTIC (50865-215-09)Marketed from Aug 17, 2017
50865-215-12508650215121200 mL in 1 BAG (50865-215-12)Marketed from Aug 17, 2017
50865-215-1950865021519237 mL in 1 BOTTLE, PUMP (50865-215-19)Marketed from Aug 17, 2017
50865-215-6550865021565800 mL in 1 BAG (50865-215-65)Marketed from Aug 17, 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 Hand Cleanser
Generic name (nonproprietary)
benzalkonium chloride
Active ingredients
Benzalkonium chloride — .013 mg/mL
Dosage form
Soap
Route
Topical
Labeler
Kutol Products CompanyNDC labeler code 50865
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2SPL ID 03fbe342-a3b7-9a63-e063-6294a90a15f2SPL set ID 56f50eda-5399-1bfe-e054-00144ff8d46cUNII F5UM2KM3W7UPC 0686702050095

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

N450865021509 followed by a unit qualifier and the quantity

Package 50865-0215-09. 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 Handwash to decrease bacteria on the skin.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50865-215

What is NDC 50865-215?
50865-215 is the product NDC for Antibacterial Hand Cleanser (benzalkonium chloride), Benzalkonium chloride .013 mg/mL soap, listed with the FDA by Kutol Products Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Antibacterial Hand Cleanser (Benzalkonium chloride).
What is the active ingredient?
Benzalkonium chloride.
Who is the labeler?
Kutol Products Company, NDC labeler code 50865. 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 Hand Cleanser?
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
PIOELLY Arnica Bruise CreamArnica montana 7 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-029
FluMisch Minoxidil Foamminoxidil,biotinMinoxidil 5 g/100mL; Biotin 5 g/100mLAerosol, FoamExtracorporealBeijing JUNGE Technology Co., Ltd.85212-0001
0.025% Capsaicin Pain relief Patchcapsaicin pain relief patch, capsaicin pain relief stripCapsaicin .025 g/100gPatchTopicalXuzhou Lanting Pharmaceutical Co., Ltd85323-005
BodyMed Alcohol Prep Padalcohol prep padIsopropyl alcohol 70 mL/100mLSwabTopicalBoxout, LLC82308-001
Senna TimesennosidesSennosides a and b 8.6 mg/1Tablet, CoatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8402
VQ Hydrating Hand Sanitizer Capri SummeralcoholAlcohol 70 mL/100mLLiquidTopicalTychea Co.85980-011
Laxative SennasennosidesSennosides 8.6 mg/1Tablet, CoatedOralTOPCO ASSOCIATES LLC36800-984
Swisherbenzalkonium chlorideBenzalkonium chloride 5 mg/mLSolutionTopicalEcolab Inc.47593-591
enMotion Antimicrobial with Moisturizers, Fragrance Freebenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLSoapTopicalGeorgia-Pacific Consumer Products LP54622-703
Sterile Alcohol Prep Pads 01isopropyl alcoholIsopropyl alcohol .7 mL/mLSwabTopicalTotal Resources International Inc.55550-222
Anti Bacterial Hand Gel Pink GumballalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6654
Anti Bacterial Hand Gel Fresh RainfallalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6930
Wet Ones Antibacterial Hand Wipes Lavender Scentbenzalkonium chlorideBenzalkonium chloride .13 g/100gSwabTopicalEdgewell Personal Care Brands LLC63354-536
Senna-Sdocusate sodium, sennosidesSennosides 8.6 mg/1; Docusate sodium 50 mg/1Tablet, Film coatedOralGranulation Technology, Inc.63561-0187
Sani-SurealcoholAlcohol 600 mL/LGelTopicalWhisk Products, Inc.65585-359
Smart Care ANTIBACTERIAL HAND SANITIZING WIPES LAVENDER SCENTbenzalkonium chlorideBenzalkonium chloride .11 g/100mLClothTopicalAshtel Studios, Inc.70108-208
4% Lidocaine Pain Relief Patchlidocaine pain relief patchLidocaine hydrochloride 4 g/100gPatchTopicalXuzhou Lanting Pharmaceutical Co., Ltd85323-002
B-Pure Moisturizing Hand Sanitizer Pink Berry Pop ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-223
Sipa hand sanitizer with Moisturizersinstant hand sanitizerAlcohol 75 mL/100mLLiquidTopicalTourel (Changsha)Hotel Supplies Co.,Ltd83502-002
VQ Hydrating Hand Sanitizer Pistachio CremealcoholAlcohol 70 mL/100mLLiquidTopicalTychea Co.85980-008

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