TYLENOL EXTRA STRENGTH

Product NDC
70264-027
11-digit product format
702640027
Labeler code
70264
Product ID
70264-027_43c8c03b-eb61-fccb-e063-6394a90a6211
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
99e45e83-37a3-44df-9a2a-98ba7457a5bbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-027-01TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET24
70264-027-01TYLENOL EXTRA STRENGTH50 in 1 BOXTABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-027TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET [R J GENERAL CORPORATION]3Current NDC, Legacy NDC, 2 package rows20241030_99e45e83-37a3-44df-9a2a-98ba7457a5bb.zip

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 13 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPEACETAMINOPHENDeMoulas Market Basket0ff5c86e-d84b-42ad-b749-636ab2e3734e2026-05-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.f7e6e984-f0c3-ed40-e053-6294a90a89f72026-05-08WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
application number: M013
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack816b65d7-e53f-44c4-a418-074279d4b2af2026-05-08WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPinnacle RX LLC513cf0e1-6874-9402-e063-6294a90aedc62026-05-07WarningsExact identifier
application number: M013
Infants Pain and Fever Cherry FlavorACETAMINOPHENGenexa Inc.19215ea7-d55f-8d81-e063-6294a90a49242026-05-07WarningsExact identifier
application number: M013
up and up acetaminophen infantsACETAMINOPHENTarget Corporationc1dd8330-fb6b-4d1f-9484-c199dc69214d2026-05-07WarningsExact identifier
application number: M013
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol Extra Strength 500 MG Oral TabletPSN99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD99e45e83-37a3-44df-9a2a-98ba7457a5bb4
198440acetaminophen 500 MG Oral TabletSCD99e45e83-37a3-44df-9a2a-98ba7457a5bb4
198440APAP 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459APAP 500 MG Oral Tablet [Tylenol]SY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol Extra Strength 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-027-017026400270150 POUCH in 1 BOX (70264-027-01) / 2 TABLET in 1 POUCH50 pouch2021-05-010000-00-00NoNoCurrent