Over-the-counter drug · OTC MONOGRAPH DRUG

Infants TYLENOL (Acetaminophen) NDC 50580-325

Acetaminophen 160 mg/5mL · Suspension · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-325Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0325Add 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
50580-325-01505800325011 BOTTLE in 1 CARTON (50580-325-01) / 60 mL in 1 BOTTLEMarketed from Sep 25, 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)
Infants TYLENOL
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 160 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 50580-325_5849b0a1-4892-7e13-e063-6394a90afea9SPL ID 5849b0a1-4892-7e13-e063-6394a90afea9SPL set ID 997b9551-c222-4a9c-8ba1-09a5f97495faRxCUI 307668, 828555UNII 362O9ITL9DUPC 0300450186607

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450580032501 followed by a unit qualifier and the quantity

Package 50580-0325-01. 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 temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-325

What is NDC 50580-325?
50580-325 is the product NDC for Infants TYLENOL (acetaminophen), Acetaminophen 160 mg/5mL suspension, listed with the FDA by Kenvue Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Infants TYLENOL (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Infants TYLENOL?
3 other product NDCs are listed under this name. See all Infants TYLENOL 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 Infants TYLENOL NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Infants TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-15450580-0154-02
Infants TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-43350580-0433-0150580-0433-02
Infants TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-59950580-0599-0150580-0599-0250580-0599-03

Other NDCs under M 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
Best Choice Effervescent Pain Reliever 36aspirinAspirin 325 mg/1Tablet, EffervescentOralVALU MERCHANDISERS COMPANY63941-241
Aspirin PacksaspirinAspirin 325 mg/1Tablet, Film coatedOralSina Health Inc70385-2006
Back and Body Extra Strengthaspirin, caffeineAspirin 500 mg/1; Caffeine 32.5 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. DBA Leader70000-0127
foster and thrive aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralStrategic Sourcing Services LLC70677-1134
Medique Pain Offacetaminophen, aspirin, caffeineCaffeine 65 mg/1 + 2 more ingredientsTablet, Film coatedOralUnifirst First Aid Corporation47682-238
Acetaminophen Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-175
Low Dose AspirinaspirinAspirin 81 mg/1Tablet, CoatedOralA-S Medication Solutions50090-4830
Childrens Pain ReliefAcetaminophen 160 mg/5mLLiquidOralAllegiant Health69168-455
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, CoatedOralMAJOR PHARMACEUTICALS0904-6783
equaline acetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-363
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralHARRIS TEETER72036-205
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-325
Excedrin Extra Strength and Excedrin Tension Headacheacetaminophen, aspirin (nsaid), and caffeine—KitHaleon US Holdings LLC0067-8151
Enteric Coated Aspirin Regular StrengthaspirinAspirin 325 mg/1Tablet, Delayed releaseOralSafeway21130-081
Headache Relief Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralH E B37808-586
DrKids Childrens Pain and Feveracetaminophen 80mg/pieceAcetaminophen 80 mg/1Bar, ChewableOralCalmCo LLC73282-2480
CAREALL Non-Aspirin PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralNew World Imports, Inc51824-069
dg health pain reliefacetaminophenAcetaminophen 500 mg/1TabletOralDolgencorp Inc55910-661
Extra Strength AcetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4065
Aspirin 81mg Dye-Freeaspirin 81mgAspirin 81 mg/1Tablet, Film coatedOralAllegiant Health69168-457

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