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 3 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact 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