NDC codes

FDA NDC Directory
Product NDC (as listed)54057-082Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54057-0082Add 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
54057-082-42540570082421250 mL in 1 PACKAGE (54057-082-42)Marketed from Aug 15, 2013

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)
chloroxylenol
Active ingredients
Chloroxylenol — .003 mg/mL
Dosage form
Liquid
Route
Topical
Labeler
Afflink, Inc.NDC labeler code 54057
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 54057-082_29b548cc-d5b2-6a5c-e063-6394a90a1be5SPL ID 29b548cc-d5b2-6a5c-e063-6394a90a1be5SPL set ID 2bda3110-edf1-438f-9bd5-49b3bb1e8aa5UNII 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

N454057008242 followed by a unit qualifier and the quantity

Package 54057-0082-42. 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 help decrease bacteria on the 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 54057-082

What is NDC 54057-082?
54057-082 is the product NDC for AFFEX Antimicrobial Foaming Hand So ap, Chloroxylenol .003 mg/mL liquid, listed with the FDA by Afflink, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
AFFEX Antimicrobial Foaming Hand So ap (Chloroxylenol).
What is the active ingredient?
Chloroxylenol.
Who is the labeler?
Afflink, Inc., NDC labeler code 54057. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for AFFEX Antimicrobial Foaming Hand So ap?
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
tazza HAND SANITIZER KING WIPESbenzalkonium chlorideBenzalkonium chloride .13 g/100gClothTopicalTazza Brands East, Inc.76370-0030
B Pure Moisturizing Hand Sanitizer Pistachio Grove ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-202
AURA LANE HAND SANITIZER Pink Lily Scentethyl alcoholAlcohol 70 mL/100mLSprayTopicalDiamond Life Cosmetics Trading FZCO87247-492
Sani-Foam Foaming Non-Alcohol Hand Sanitizerbenzalkonium chlorideBenzalkonium chloride 1 mg/mLSolutionTopicalMulti-Clean62767-104
Anti Bacterial Hand Gel Pink Kiwi BerryalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6831
Altra Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloebenzalkonium chlorideBenzalkonium chloride .12 g/100mLSolutionTopicalBuckeye International, Inc.30805-015
eZFoam Foaming Alcohol Hand Sanitizerfoaming hand sanitizerAlcohol 62 mL/100mLSolutionTopicalKutol Products Company50865-688
Stool Softener Laxativedocusate sodium and sennosidesDocusate sodium 50 mg/1; Sennosides 8.6 mg/1TabletOralSafeway, Inc.21130-855
Vegetable LaxativesennosidesSennosides 8.6 mg/1Tablet, Film coatedOralCHAIN DRUG MARKETING ASSOCIATION INC63868-579
Smart Care BERRY HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios Inc.70108-110
GoodEarth Sanitizing Wipesbenzalkonium chlorideBenzalkonium chloride 3.822 mg/1ClothTopicalGoodEarth Distribution LLC71745-003
Tazza Antiseptic Hand Wipesisopropyl alcoholIsopropyl alcohol 75 mL/100mLClothTopicalTazza Brands East Inc.76370-0012
JuniperClean Rosejuniper clean hand soap roseBenzalkonium chloride .13 g/100gLiquidTopicalKYNC Design LLC76557-017
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-199
SOUR LEMON HAND SANITIZER Vanilla Berry SCENTethyl alcoholAlcohol 70 mL/100mLSprayTopicalDiamond Life Cosmetics Trading FZCO87247-489
Anti Bacterial Hand Gel Sunlit Palm TreesalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6828
Altra Foaming Hand Sanitizer with Aloe and Vitamin EalcoholAlcohol 62 mL/100mLSolutionTopicalBuckeye International, Inc.30805-012
Zoono Alcohol Free Hand Sanitizerbenzalkonium chlorideBenzalkonium chloride .13 g/100mLSolutionTopicalZoono Holdings USA LLC69221-601
Eucalyptol, Menthol, Methyl Salicylate, ThymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralStrategic Sourcing Services LLC70677-1232
Fragrance Free Sanitizing Wipesbenzalkonium chlorideBenzalkonium chloride 1.3 mg/1ClothCutaneousGoodEarth Distribution Llc71745-001

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