Over-the-counter drug · OTC MONOGRAPH DRUG

Tylenol Extra Strength (Acetaminophen) NDC 50580-937

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

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-937Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0937Add 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
50580-937-01505800937015058009370112 VIAL in 1 PACKAGE (50580-937-01) / 10 TABLET, FILM COATED in 1 VIALMarketed from Aug 19, 2019
50580-937-02505800937025058009370212 VIAL in 1 PACKAGE (50580-937-02) / 10 TABLET, FILM COATED in 1 VIALMarketed from Sep 16, 2019
50580-937-0650580093706505800937061 BOTTLE in 1 CARTON (50580-937-06) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 31, 2020
50580-937-0750580093707505800937071 BOTTLE in 1 CARTON (50580-937-07) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 31, 2020
50580-937-1050580093710505800937101 BOTTLE in 1 CARTON (50580-937-10) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 31, 2020
50580-937-1550580093715505800937151 BOTTLE in 1 CARTON (50580-937-15) / 225 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 31, 2020
50580-937-195058009371950580093719325 TABLET, FILM COATED in 1 BOTTLE (50580-937-19)Marketed from Aug 31, 2020
50580-937-2350580093723505800937233 POUCH in 1 CARTON (50580-937-23) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jan 15, 2026
50580-937-2550580093725505800937252500 POUCH in 1 CASE (50580-937-25) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Dec 28, 2025
50580-937-375058009373750580093737320 TABLET, FILM COATED in 1 BOTTLE (50580-937-37)Marketed from Mar 31, 2026
50580-937-50505800937505058009375050 POUCH in 1 CARTON (50580-937-50) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Dec 28, 2025
50580-937-51505800937515058009375150 POUCH in 1 CARTON (50580-937-51) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Dec 28, 2025
50580-937-6650580093766505800937662 BOTTLE in 1 CARTON (50580-937-66) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from May 1, 2024

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 50580-937_572fcd5f-40f6-eaf1-e063-6294a90a4143SPL ID 572fcd5f-40f6-eaf1-e063-6294a90a4143SPL set ID 103d109d-f520-409c-8da2-eb6b0fbec891RxCUI 198440, 209459UNII 362O9ITL9DUPC 0300450449108

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

N450580093701 followed by a unit qualifier and the quantity

Package 50580-0937-01. 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 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 50580-937

What is NDC 50580-937?
50580-937 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 13 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/1Tablet, Film coatedOralKenvue Brands LLC50580-45750580-0457-1050580-0457-1150580-0457-70
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

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
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralGrocery Outlet, Inc.85828-922
Pain Relief Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC83324-076
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
good neighbor pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-210
AspirinAspirin 81 mg/1Tablet, Delayed releaseOralGOODSENSE50804-880
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralMorning Star OTC53209-1002
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
childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreen Company0363-1239
Tylenol PMacetaminophen, diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-013
Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonateAnhydrous citric acid 1000 mg/1 + 2 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-4000
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1260
basic care infants pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-946
AcetaminophenAcetaminophen 500 mg/1TabletOralSportpharm LLC85766-223
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralUnited Natural Foods, Inc. dba UNFI41163-421
Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralChain Drug Consortium, LLC68016-154
Tension Headache ReliefAcetaminophen 500 mg/1; Caffeine 65 mg/1Capsule, CoatedOralAllegiant Health69168-001
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralProficient Rx LP71205-263
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-075

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