Over-the-counter drug · OTC MONOGRAPH DRUG

TYLENOL Extra Strength (Acetaminophen) NDC 50580-457

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-457Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0457Add 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
50580-457-10505800457101 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jul 10, 2020
50580-457-115058004571110 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 17, 2020
50580-457-7050580045770700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70)Marketed from Jul 17, 2020

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)
TYLENOL Extra Strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Film coated
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 50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7SPL ID 2ddb1260-fde6-1914-e063-6394a90a82d7SPL set ID c830320e-72ba-48ff-a4cd-250ac5650bf0RxCUI 198440, 209459UNII 362O9ITL9D

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

N450580045710 followed by a unit qualifier and the quantity

Package 50580-0457-10. 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 relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-457

What is NDC 50580-457?
50580-457 is the product NDC for TYLENOL Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TYLENOL Extra Strength (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 TYLENOL Extra Strength?
23 other product NDCs are listed under this name. See all TYLENOL Extra Strength 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 TYLENOL Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TYLENOL Extra StrengthacetaminophenAcetaminophen 960 mg/30mLSuspensionOralKenvue Brands LLC50580-18750580-0187-08
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-46950580-0469-1850580-0469-4050580-0469-75
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-10850580-0108-25
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-49150580-0491-0150580-0491-1050580-0491-70
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-47250580-0472-0150580-0472-0250580-0472-03+1 more
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralR J General Corporation70264-02770264-0027-01
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralKenvue Brands LLC50580-49050580-0490-0250580-0490-1050580-0490-20+4 more
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/.95gPowderOralKenvue Brands LLC50580-20950580-0209-0250580-0209-04
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-546950090-5469-00
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-93750580-0937-0150580-0937-0250580-0937-06+10 more

All 24 TYLENOL Extra Strength NDCs

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
Xesso NeobenzocaineBenzocaine 5 g/100mLSprayOral, TopicalPREMIUM NATURAL COSMETICS INC81777-106
MAX relief junior Grapechildrens acetaminophenAcetaminophen 160 mg/5mLLiquidOralATLANTIC BIOLOGICALS CORP.17856-1123
equate aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralWal-Mart Stores Inc49035-467
AcetaminophenAcetaminophen 325 mg/1TabletOralCardinal Health 107, LLC55154-7899
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-346
Bayer Rapid Reliefaspirin/caffeine oral powderCaffeine 65 mg/1; Aspirin 650 mg/1PowderOralBayer HealthCare LLC.0280-0103
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-3141
Headache Reliefacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralDOLGENCORP, LLC55910-345
Aspirin Enteric Coated, Regular StrengthaspirinAspirin 325 mg/1Tablet, Delayed releaseOralWalgreen Company0363-0227
AspirinAspirin 325 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-205
MAX relief junior Grapechildrens acetaminophenAcetaminophen 160 mg/5mLLiquidOralATLANTIC BIOLOGICALS CORP.17856-1122
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralH E B37808-195
childrens mapapacetaminophenAcetaminophen 160 mg/1Tablet, ChewableOralProficient Rx LP71205-322
AcetaminophenAcetaminophen 500 mg/1TabletOralWALMART INC79903-296
Extra Strength Pain Relieveracetaminophen 500 mgAcetaminophen 500 mg/1TabletOralLil' Drug Store Products, Inc.29485-9281
AcetaminophenAcetaminophen 500 mg/1TabletOralCardinal Health 107, LLC55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-334
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-751
Alka-Seltzerbuffered aspirinAspirin 325 mg/1Tablet, EffervescentOralLil' Drug Store Products, Inc.66715-5206
Extra Strength Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8786

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