FDA.reportPublic FDA data

Acetaminophen

Product NDC
55289-880
11-digit product format
552890880
Labeler code
55289
Product ID
55289-880_48390181-cda8-a543-e063-6294a90a5896
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-01-10
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
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
64696f65-415e-4ce1-a5b3-70662fbcb002Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-880-01Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10017
55289-880-06Acetaminophen6 in 1 BOTTLE, PLASTICTABLET617
55289-880-12Acetaminophen12 in 1 BOTTLE, PLASTICTABLET1217
55289-880-20Acetaminophen20 in 1 BOTTLE, PLASTICTABLET2017
55289-880-21Acetaminophen21 in 1 BOTTLE, PLASTICTABLET2117
55289-880-24Acetaminophen24 in 1 BOTTLE, PLASTICTABLET2417
55289-880-30Acetaminophen30 in 1 BOTTLE, PLASTICTABLET3017
55289-880-50Acetaminophen50 in 1 BOTTLE, PLASTICTABLET5017
55289-880-60Acetaminophen60 in 1 BOTTLE, PLASTICTABLET6017
55289-880-97Acetaminophen200 in 1 BOTTLE, PLASTICTABLET20017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-880-01EA - Each55289-8803621471c-519c-4210-a424-75923dbb1b5e12018-02-20
55289-880-06EA - Each55289-8801b164f4d-7a27-471b-a717-0551ba92e9f212021-04-08
55289-880-12EA - Each55289-88037d5d2bb-55da-4df6-b732-b94a7cffc30a12021-04-08
55289-880-20EA - Each55289-88052048397-7c8c-4ea1-96d5-872bd632b8d612019-10-07
55289-880-21EA - Each55289-8807bf835ba-94a6-49b1-b430-cdab47db0b6512026-01-08
55289-880-24EA - Each55289-880ddab36f9-cd9b-48b1-b340-0ccf7d36a2ed12018-02-20
55289-880-30EA - Each55289-88053a6c6a1-52e8-48b7-a2db-9f343f67db2512018-02-20
55289-880-50EA - Each55289-88095999b98-63df-4bc0-979b-cc155dc09fb612021-04-08
55289-880-60EA - Each55289-880863de181-0e5d-4194-913e-aa7b52eaea7412021-04-08
55289-880-97EA - Each55289-880a7d31359-ca89-445e-9ab6-d454707412c412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-880ACETAMINOPHEN TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 10 package rows20250322_64696f65-415e-4ce1-a5b3-70662fbcb002.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 32 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC422796ed-7558-f7e8-e063-6294a90ad1c72025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e61abe4-b4be-01af-e063-6394a90a8b242025-11-20WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
application number: M013
ASPIRINASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED54e4ae54-caf8-4105-8428-256f56a2f68f2025-11-19WarningsExact identifier
application number: M013
MIDOL COMPLETEACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATER J General Corporation0c09a178-1a07-4079-b4a6-d1657cb8e7142025-11-17WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
application number: M013
MOTRIN IBIBUPROFENR J General Corporationafa87bb5-7fcb-4ccd-acac-f7931242181f2025-11-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENR J General Corporation99e45e83-37a3-44df-9a2a-98ba7457a5bb2025-11-17WarningsExact identifier
application number: M013
TYLENOL PM EXTRA STRENGTHACETAMINOPHENR J General Corporationa40ea0e3-d666-4605-b5e0-beeaf8f586f22025-11-17WarningsExact identifier
application number: M013
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MGR J General Corporation68d3be55-9340-4cc9-a05a-12b9338ddc562025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationdd9aaf80-6c2b-41a3-87b9-61642aaed4f02025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c18a2da-1718-4c00-aea8-9fb4a34183122025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationcd3060a5-3b90-42e4-89cd-3b620859045f2025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c7221ae-52d1-4d18-b586-c47ff656150d2025-11-17WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINER J General Corporation907c89e7-2482-465f-9f85-2381ecab1b862025-11-17WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINR J General Corporation23daa359-d40f-4f64-81be-6d154f41df9f2025-11-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN64696f65-415e-4ce1-a5b3-70662fbcb00217
198440acetaminophen 500 MG Oral TabletSCD64696f65-415e-4ce1-a5b3-70662fbcb00217
198440APAP 500 MG Oral TabletSY64696f65-415e-4ce1-a5b3-70662fbcb00217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-880-0155289088001100 TABLET in 1 BOTTLE, PLASTIC (55289-880-01) 100 tablet2018-01-120000-00-00NoNoCurrent
55289-880-06552890880066 TABLET in 1 BOTTLE, PLASTIC (55289-880-06) 6 tablet2021-03-260000-00-00NoNoCurrent
55289-880-125528908801212 TABLET in 1 BOTTLE, PLASTIC (55289-880-12) 12 tablet2021-03-260000-00-00NoNoCurrent
55289-880-205528908802020 TABLET in 1 BOTTLE, PLASTIC (55289-880-20) 20 tablet2019-09-090000-00-00NoNoCurrent
55289-880-215528908802121 TABLET in 1 BOTTLE, PLASTIC (55289-880-21) 21 tablet2025-12-16NoNoCurrent
55289-880-245528908802424 TABLET in 1 BOTTLE, PLASTIC (55289-880-24) 24 tablet2025-05-290000-00-00NoNoCurrent
55289-880-305528908803030 TABLET in 1 BOTTLE, PLASTIC (55289-880-30) 30 tablet2018-01-120000-00-00NoNoCurrent
55289-880-505528908805050 TABLET in 1 BOTTLE, PLASTIC (55289-880-50) 50 tablet2021-03-260000-00-00NoNoCurrent
55289-880-605528908806060 TABLET in 1 BOTTLE, PLASTIC (55289-880-60) 60 tablet2021-03-260000-00-00NoNoCurrent
55289-880-9755289088097200 TABLET in 1 BOTTLE, PLASTIC (55289-880-97) 200 tablet2021-03-260000-00-00NoNoCurrent