TYLENOL Extra Strength

Product NDC
85237-1946
11-digit product format
852371946
Labeler code
85237
Product ID
85237-1946_5543ed1a-4081-afdd-e063-6394a90aa77b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Consumer Group LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1984-08-19
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TYLENOL Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
529d3a51-a248-7c02-e063-6294a90a10aeAvailable on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 34 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalmart Inc.1557bd9b-3e7c-4769-e063-6394a90a9d912025-11-04WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINRising Pharma Holdings, Inc.c3c4854e-726e-4926-b044-a5094943c3062025-11-04WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e50b3f6-1e1a-41b9-e063-6394a90abe362025-11-03WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company447de441-7d28-4415-81c5-4fc05622dd052025-11-03WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENVERITYRX. LLC42a17f54-7851-84fb-e063-6394a90a9ec12025-11-02WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENVERITYRX, LLC42a1a128-a2dd-bbc9-e063-6294a90a4fe12025-11-02WarningsExact identifier
application number: M013
Physicians Care AspirinASPIRINAcme United Corporationaa67ea3a-2741-7ee0-e053-2a95a90a64852025-10-31WarningsExact identifier
application number: M013
PhysiciansCare Non Aspirin Extra StrengthACETAMINOPHENAcme United Corporationc7006775-bd5b-412f-963d-ce5a158216c52025-10-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreensf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba2025-10-31WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENNuCare Pharmaceuticals, Inc.41affa1a-5aac-7fc0-e063-6394a90a55572025-10-30WarningsExact identifier
application number: M013
MAPAP Extra StrengthACETAMINOPHENMajor Pharmaceuticals34a95450-3f04-4de4-9113-73e7bd5724a02025-10-29WarningsExact identifier
application number: M013
GOODNOW PAIN RELIEFACETAMINOPHENGobrands, Inc4d4a78a5-5a88-4f24-b685-c7c6bb5e989e2025-10-29WarningsExact identifier
application number: M013
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.f8237772-7656-49fb-b1de-f8fcb5fa55ee2025-10-28WarningsExact identifier
application number: M013
DG Health Pain ReliefACETAMINOPHENDolgencorp Inc42f0c87c-7020-4af7-9f6b-3a774137e5642025-10-24WarningsExact identifier
application number: M013
GOODYS HangoverASPIRIN AND CAFFEINEMedtech Products Inc.0b0067e0-58b0-4581-aa4b-e398c32c559a2025-10-23WarningsExact identifier
application number: M013
GOODYS Extra Strength Headache Mixed Fruit BlastACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.6cb758bf-5a50-46bb-96e7-65b810b12de02025-10-23WarningsExact identifier
application number: M013
Nyt Time Sleep CapsDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MARTe3f4d063-921d-4503-89a6-26cc9c46b4c92025-10-23WarningsExact identifier
application number: M013
AnacinASPRIN AND CAFFEINEInsight Pharmaceuticals LLC51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff2025-10-23WarningsExact identifier
application number: M013
Goodys Back and Body PainACETAMINOPHEN AND ASPRINMedtech Products Inc.055d0288-61d4-48bc-b91f-6ecc1969beb82025-10-23WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1946-1852371946011 POUCH in 1 BLISTER PACK (85237-1946-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 1 pouch2025-06-04NoNoCurrent
85237-1946-2852371946022 POUCH in 1 BLISTER PACK (85237-1946-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 2 pouch2025-06-04NoNoCurrent
85237-1946-38523719460320 POUCH in 1 CARTON (85237-1946-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 20 pouch2025-06-04NoNoCurrent
85237-1946-48523719460425 POUCH in 1 CARTON (85237-1946-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 25 pouch2025-06-04NoNoCurrent
85237-1946-58523719460530 POUCH in 1 CARTON (85237-1946-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 30 pouch2025-06-04NoNoCurrent
85237-1946-68523719460650 POUCH in 1 CARTON (85237-1946-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 50 pouch2025-06-04NoNoCurrent
85237-1946-7852371946073 POUCH in 1 BLISTER PACK (85237-1946-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 3 pouch2025-06-04NoNoCurrent