NDC codes

FDA NDC Directory
Product NDC (as listed)54057-083Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54057-0083Add 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
54057-083-42540570083421250 mL in 1 PACKAGE (54057-083-42)Marketed from Nov 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 54057-083_297b2a97-abd1-a1c4-e063-6394a90ab946SPL ID 297b2a97-abd1-a1c4-e063-6394a90ab946SPL set ID d97c8bb5-78a7-44e0-b68d-890b00f171d8UNII 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

N454057008342 followed by a unit qualifier and the quantity

Package 54057-0083-42. 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 54057-083

What is NDC 54057-083?
54057-083 is the product NDC for AFFEX Foaming Antimicrobial 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 Foaming Antimicrobial 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 Foaming Antimicrobial 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
BATANA Oilbatana oil, rosemary oil, biotinRosemary oil .005 g/mL + 2 more ingredientsLiquidTopicalShenzhen Boyimei Technology Co., Ltd.85992-006
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonalcoholAlcohol 70 mL/100mLSprayTopicalChurch & Dwight Co., Inc.10237-128
Oral Sore Antiseptichydrogen peroxide, mentholHydrogen peroxide 1.5 mg/mL; Menthol 1 mg/mLLiquidOralRite Aid Corporation11822-3024
Antispeticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralThe Kroger Co.30142-664
EcoCare 280benzalkonium chlorideBenzalkonium chloride 5 mg/mLSolutionTopicalEcolab Inc.47593-646
Healthcetylpyridinium chlorideCetylpyridinium chloride .7 mg/mLMouthwashOralOld East Main Co.55910-299
EnMotion Foam Hand Sanitizerethyl alcoholAlcohol 70 mL/100mLLiquidTopicalGeorgia-Pacific Consumer Products LP54622-120
Anti Bacterial Hand Gel Disney Princess MoanaalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6879
Secura Moisturizing Cleanserbenzethonium chlorideBenzethonium chloride 1.3 ug/mLSprayTopicalSmith & Nephew Medical Ltd69740-309
Isopropyl AlcoholIsopropyl alcohol 700 mL/LSprayTopicalProvision Medical69103-5500
Fresh Feels Hand Sanitizer Mist Blue Raspberry Scentethyl alcoholAlcohol 70 mL/100mLSprayTopicalPearl World Inc.69933-261
Smart Care TRANSFORMERS HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios, Inc.70108-163
My-Shield Sanitizing Hand Wipesbenzalkonium chlorideBenzalkonium chloride 1.3 mg/gSwabTopicalENVIRO SPECIALTY CHEMICALS INC71884-010
Hand SanitizeralcoholAlcohol .75 mL/mLSprayTopicalORR Safety Corporation79401-000
SennasennosidesSennosides 8.6 mg/1TabletOralQUALITY CHOICE (Chain Drug Marketing Association)83324-004
5% MINOXIDIL HAIR REGROWTH SERUM With BiotinminoxidilMinoxidil .05 g/mLLiquidTopicalShenzhen Huayuan Hengsheng Technology Co., Ltd.87394-001
Hand Washbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalMeijer, Inc.41250-661
DigiSanalcoholAlcohol .547 mg/mgAerosol, FoamTopicalEcolab Inc.47593-618
Senna laxativesennosidesSennosides 8.6 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-882
AntiBacterialHandSpray Winter Candy ApplealcoholAlcohol 72 mL/100mLSprayTopicalBath & Body Works, Inc.62670-6602

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