Over-the-counter drug · OTC MONOGRAPH DRUG

Benzalkonium chloride NDC 11344-628

Benzalkonium chloride 1.3 mg/mL · Liquid · Topical · Nice-Pak Products, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)11344-628Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11344-0628Add 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
11344-628-4511344062845946 mL in 1 BOTTLE, PLASTIC (11344-628-45)Marketed from Dec 20, 2016
11344-628-9611344062896221 mL in 1 BOTTLE, PUMP (11344-628-96)Marketed from Dec 20, 2016

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)
Benzalkonium chloride
Generic name (nonproprietary)
benzalkonium chloride
Active ingredients
Benzalkonium chloride — 1.3 mg/mL
Dosage form
Liquid
Route
Topical
Labeler
Nice-Pak Products, LLCNDC labeler code 11344
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 11344-628_58b3faa1-2662-1378-e063-6394a90a330fSPL ID 58b3faa1-2662-1378-e063-6394a90a330fSPL set ID e368e7b8-9695-4dd8-a49b-8c17c24c7f51RxCUI 1046593UNII F5UM2KM3W7

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

N411344062845 followed by a unit qualifier and the quantity

Package 11344-0628-45. 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 handwashing 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 11344-628

What is NDC 11344-628?
11344-628 is the product NDC for Benzalkonium chloride, Benzalkonium chloride 1.3 mg/mL liquid, listed with the FDA by Nice-Pak Products, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Benzalkonium chloride.
What is the active ingredient?
Benzalkonium chloride.
Who is the labeler?
Nice-Pak Products, LLC, NDC labeler code 11344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Benzalkonium chloride?
32 other product NDCs are listed under this name. See all Benzalkonium chloride 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 Benzalkonium chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Benzalkonium chlorideBenzalkonium chloride .13 mg/mLSwabTopicalUpLift Brands, LLC83986-91283986-0912-2083986-0912-90
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-09459640-0094-4559640-0094-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-14959640-0149-4559640-0149-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-25259640-0252-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-27359640-0273-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-29059640-0290-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-30659640-0306-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-31759640-0317-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-32159640-0321-96
Benzalkonium ChlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalH E B59640-37359640-0373-96

All 33 Benzalkonium chloride 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
Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralTopco Associates LLC76162-855
Chai Latte Scented Clip On Hand SanitizeralcoholAlcohol 70 mL/100mLGelTopicalFourstar Group USA, Inc.80684-062
KeriCure Hand SanitizeralcoholAlcohol 70 mL/100mLSprayTopicalKericure Inc.78280-304
San-A-GelAlcohol 67 mL/100mLLiquidTopicalMisco Industrial, LLC82041-693
AlcoholAlcohol 70 mL/100mLGelTopicalTARGET CORPORATION INC.82442-003
Tork Foam Antibacterialbenzalkonium chlorideBenzalkonium chloride .13 g/100mLSoapTopicalEssity Professional Hygiene North America LLC49351-104
Hair Growth FoamminoxidilMinoxidil 5 g/100mLAerosol, FoamTopicalShenzhen Shandian Jingling Technology Co., Ltd.83804-008
aromatica hair acondicionador romero con minoxidilminoxidilMinoxidil 2 mg/473mLRinseTopicalLABORATORIO MK SRL87022-012
XtraCare Hand Sanitizer Antibacterial Moisturize with Vitamin E and AloealcoholAlcohol 70 mL/100mLGelTopicalRejoice Industries Canada Inc.87559-001
Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralNice-Pak Products, LLC11344-855
PURELL Advanced Instant Hand SanitizeralcoholAlcohol .7 mL/mLLiquidTopicalGOJO Industries, Inc.21749-807
ATTITUDE Super Leaves Hand Sanitizer Lemon Leavesethyl alcoholAlcohol 78.8 mL/100mLSolutionTopical9055-7588 Quebec Inc. DBA Attitude61649-293
Peepin It Real Disney Villains MaleficentalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7030
Anti Bacterial Hand Gel Champagne In ParisalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6769
Smart Care 2 HAND SANITIZERS 1.35 FL OZ (CHAMPAGNE TOAST, SPARKLING POMEGRANATE)ethyl alcohol—KitAshtel Studios, Inc.70108-399
Antibacterial Hand Sanitizerethyl alcoholAlcohol 620 mg/mLGelTopicalZhejiang Ayan Biotech Co.,Ltd.70412-112
Wet Wipes Antibacterial Hand Wipes, Travel Packbenzethonium chlorideBenzethonium chloride 1.3 mg/mLClothTopicalGlobal Import Sales LLC72146-037
AlcoholAlcohol 62 mL/100mLLiquidTopicalAmazon.com Services LLC72288-826
Antiseptic Mouthrinseeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralWalmart Inc.49035-072
hair treatmentminoxidilMinoxidil 1 mg/473mLCreamTopicalLABORATORIO MK SRL87022-009

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