FDA.reportPublic FDA data

Acetaminophen

Product NDC
55301-519
11-digit product format
553010519
Labeler code
55301
Product ID
55301-519_22c2ed82-d9d4-4ab9-8faa-01267b908876
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
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
Acetaminophen
Brand name suffix
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3feca65-adc1-469f-bef6-12c860599abeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-519-51AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED119
55301-519-51AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED5019
55301-519-60AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED119
55301-519-60AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-519ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]17Current NDC, Legacy NDC, 4 package rows20240608_f3feca65-adc1-469f-bef6-12c860599abe.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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companyb4d8860b-d72f-4789-945e-1c6420a8efab2025-12-02WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREEN COMPANYf7b304d8-e37c-4ac6-b4a2-1797b92cb8322025-12-01WarningsExact identifier
application number: M013
Dye FreeInfants Pain and FeverACETAMINOPHENWALGREEN COMPANY1a304570-88b6-4c16-a8b4-c064bfa5d95a2025-12-01WarningsExact identifier
application number: M013
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWALGREEN CO.6c4ab613-a587-4ec4-9986-f1d000bc2d232025-12-01WarningsExact identifier
application number: M013
WAG HBP Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.ac2f9ce8-e402-4451-a412-e99248a6ecbe2025-12-01WarningsExact identifier
application number: M013
Walgreen Day Time NightTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESINWALGREENS CO.5505217a-9679-4668-bdab-5d4553a47c562025-12-01WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Inc58a371d4-1f00-4fda-8e08-80610c58505a2025-12-01WarningsExact identifier
application number: M013
CareALL Non Aspirin Extra StrengthACETAMINOPHENNew World Imports, Incda05a1a1-35b4-4787-8c56-12e369f18ff02025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc80a699b9-bf5c-4765-9e20-ccbc7e3ace7a2025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
application number: M013
Family Wellness Childrens Pain Reliever 574ACETAMINOPHENFamily Dollar Services, Inc.902c1136-04d2-41f0-81c6-412663cdf3782025-12-01WarningsExact identifier
application number: M013
WalgreenChildrens Pain FeverACETAMINOPHENWALGREENS CO.2f757cde-2604-4ca4-b54e-e444f3757cdd2025-11-26WarningsExact identifier
application number: M013
Walgreen Childrens Pain plus FeverACETAMINOPHENWALGREENS CO.29ca2855-3c07-435d-a8e1-2997fcedd0882025-11-26WarningsExact identifier
application number: M013
Walgreens Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.8714d4e6-3a3b-48c8-8ac1-51b933a2ceac2025-11-26WarningsExact identifier
application number: M013
Pain Reliever, 24/7 Life by 7-ElevenACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.44828b89-2563-b233-e063-6294a90ab1242025-11-26WarningsExact identifier
application number: M013
MEMBERS MARK ACETAMINOPHENACETAMINOPHENSam's West Inc03e831d4-8060-4633-9d02-e77100063fb42025-11-26WarningsExact identifier
application number: M013
Childrens Pain and Fever Dissolve PacksACETAMINOPHENWALGREENS CO.ea0f265f-7d64-4731-beda-0bb841dd1ad72025-11-25WarningsExact identifier
application number: M013
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.71a80e13-bda3-40fb-b4e7-45e9985e707c2025-11-24WarningsExact identifier
application number: M013
better living brands childrens fever and pain reliverACETAMINOPHENBETTER LIVING BRANDS LLCc13ced61-c491-4fc2-b83f-78c6d9ad85462025-11-20WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-519-51553010519511 BOTTLE, PLASTIC in 1 CARTON (55301-519-51) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
55301-519-60553010519601 BOTTLE, PLASTIC in 1 CARTON (55301-519-60) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent