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

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 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Children Pain Relief GummyACETAMINOPHEN CHILDREN GUMMYGummy USA5513db67-f023-7f47-e063-6294a90a27572026-07-24WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCce58105b-f010-47af-8f31-6dd4ce4e9cba2026-07-22WarningsExact identifier
application number: M013
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company0ad7b313-5d72-4cc0-97f0-1a30770350af2026-07-22WarningsExact 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