NDC codes

FDA NDC Directory
Product NDC (as listed)35000-254Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35000-0254Add 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
35000-254-113500002541135000025411332 mL in 1 BOTTLE (35000-254-11)Marketed from Oct 4, 2022
35000-254-9135000025491350000254911470 mL in 1 BOTTLE (35000-254-91)Marketed from Dec 14, 2022

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

Generic name (nonproprietary)
benzalkonium chloride
Active ingredients
Benzalkonium chloride — 1.33 mg/mL
Dosage form
Liquid
Route
Topical
Labeler
COLGATE PALMOLIVE COMPANYNDC labeler code 35000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 35000-254_4ba9807b-0d5f-4688-a685-10eb167c6ea7SPL ID 4ba9807b-0d5f-4688-a685-10eb167c6ea7SPL set ID 7d48e018-0874-4bbf-a95e-dc21702406c1RxCUI 1046593UNII F5UM2KM3W7UPC 0827854007265

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

N435000025411 followed by a unit qualifier and the quantity

Package 35000-0254-11. 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 helps eliminate bacteria on hands

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35000-254

What is NDC 35000-254?
35000-254 is the product NDC for Softsoap Antibacterial Clean and Protect Cool Splash, Benzalkonium chloride 1.33 mg/mL liquid, listed with the FDA by COLGATE PALMOLIVE COMPANY. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Softsoap Antibacterial Clean and Protect Cool Splash (Benzalkonium Chloride).
What is the active ingredient?
Benzalkonium 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 Softsoap Antibacterial Clean and Protect Cool Splash?
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
Pretty Pump Hand SanitizeralcoholAlcohol 600 mL/LSprayTopicalWhisk Products, Inc.65585-489
Protec Hand Sani Gel AntibacterialalcoholAlcohol .7 mL/mLGelTopicalDegasa, S.A. de C.V.67326-006
Foaming Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 g/1000mLSolutionTopicalSam's West, Inc.68196-667
Smart Care TEA and TIMBER HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios, Inc.70108-199
B-Pure Moisturizing Hand Sanitizer Warm Cashmere ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-217
VQ Hydrating Hand Sanitizer Frosted Candy ApplealcoholAlcohol 67.5 mL/100mLLiquidTopicalTychea Co.85980-024
BCBG GENERATION HAND SANITIZER DUO - WILD Cherry AND Mango Cherry SCENTethyl alcohol—KitDiamond Life Cosmetics Trading FZCO87247-933
Anti Bacterial Hand Gel GinghamalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6641
Anti Bacterial Hand Gel Disney Villains Evil QueenalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6919
Povidone-Iodine Prep Winged Sterile Largepovidone-iodinePovidone-iodine 100 mg/gSpongeTopicalCardinal Health 200, Inc63517-759
Smart-San Hand Sanitizer FoamalcoholAlcohol 74 mL/100mLLiquidTopicalBest Sanitizers, Inc.59900-352
BZK Antiseptic Towelette Sterilebenzalkonium chlorideBenzalkonium chloride 1.3 mg/gClothTopicalJianerkang Medical Co., Ltd34645-0018
Lavender Hand Sanitizing WipesethanolAlcohol 65 mL/100mLClothTopicalWhole Foods Market, Inc.42681-6810
Pacific Blue ultra Antimicrobial Foam Fragrance Freebenzalkonium chlorideBenzalkonium chloride .13 g/100mLSolutionTopicalGeorgia-Pacific Consumer Products54622-316
Zylast Antiseptic Sethyl alcoholAlcohol 760 mL/1000mLLiquidTopicalInnovative BioDefense57362-466
WhiskCare 375alcoholAlcohol 600 mL/LGelTopicalWhisk Products, Inc.65585-375
GuruNanda Healthy Gumscetylpyridinium chlorideCetylpyridinium chloride 1 mg/mLMouthwashOralGURUNANDA, LLC70708-926
Smart Care SWEET AND STILL HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios, Inc.70108-192
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-214
RootStim Minoxidil Hair Regrowth TreatmentminoxidilMinoxidil 5 g/100mLLiquidTopicalYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD83364-025

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