Over-the-counter drug · OTC MONOGRAPH DRUG

TYLENOL Extra Strength (Acetaminophen) NDC 53209-1001

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Morning Star OTC

NDC codes

FDA NDC Directory
Product NDC (as listed)53209-1001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53209-1001Add 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
53209-1001-2532091001025320910010225 BLISTER PACK in 1 POUCH (53209-1001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1001-1)Marketed from Jun 19, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Morning Star OTCNDC labeler code 53209
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 53209-1001_37e8d749-91bb-a5bc-e063-6394a90ac8a8SPL ID 37e8d749-91bb-a5bc-e063-6394a90ac8a8SPL set ID 8502ea21-937d-4b33-a3e0-ffab5dc38cd8RxCUI 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

N453209100102 followed by a unit qualifier and the quantity

Package 53209-1001-02. 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 53209-1001

What is NDC 53209-1001?
53209-1001 is the product NDC for TYLENOL Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Morning Star OTC. It has 1 package NDC, 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?
Morning Star OTC, NDC labeler code 53209. 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
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCOSTCO WHOLESALE CORPORATION63981-019
Extra Strength Pain ReleifacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralStrategic Sourcing Services, LLC70677-1242
Aspirin 81 mgaspirinAspirin 81 mg/1Tablet, Delayed releaseOralH E B37808-600
Extra Strength Pain Relieveracetaminophen tablets 500 mgAcetaminophen 500 mg/1TabletOralWALGREENS0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)Acetaminophen 500 mg/1Capsule, Liquid filledOralWalgreens0363-6684
Mommys Bliss Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-793
Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralCVS Pharmacy59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-211
AcetaminophenAcetaminophen 160 mg/5mLLiquidOralA-S Medication Solutions50090-6059
Members Mark AcetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralSam's West Inc68196-606
Mommys Bliss Infants Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-893
Thompson Extra Strength Non-AspirinacetaminophenAcetaminophen 500 mg/1TabletOralThompson73408-174
Aspirin 81 mg Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-089
AcetaminophenAcetaminophen 500 mg/1TabletOralASCLEMED USA INC.87063-222
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralP & L Development, LLC49580-0282
Dye Free Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreens0363-0285
Pain Reliever Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralWalgreen Company0363-0519
Aspirin 81 mg Low doseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-090

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