FDA.reportPublic FDA data

acetaminophen

Product NDC
11822-4484
11-digit product format
118224484
Labeler code
11822
Product ID
11822-4484_063fe4f3-5ef2-4c8b-a8a5-7adeab4dde00
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-04
Marketing end
2026-12-31
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-448411822-4484-2DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-448411822-4484-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

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
a8bb4f45-7a1a-4bf7-92ca-3afd508032f3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4484-1acetaminophen1 in 1 CARTONTABLET16
11822-4484-1acetaminophen225 in 1 BOTTLETABLET2256
11822-4484-2acetaminophen1000 in 1 BOTTLETABLET10006
11822-4484-3acetaminophen24 in 1 BOTTLETABLET246
11822-4484-3acetaminophen1 in 1 CARTONTABLET16
11822-4484-4acetaminophen50 in 1 BOTTLETABLET506
11822-4484-4acetaminophen1 in 1 CARTONTABLET16
11822-4484-5acetaminophen1 in 1 CARTONTABLET16
11822-4484-5acetaminophen100 in 1 BOTTLETABLET1006
11822-4484-6acetaminophen500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4484ACETAMINOPHEN TABLET [RITE AID CORPORATION]5Current NDC, Legacy NDC, 10 package rows20241116_a8bb4f45-7a1a-4bf7-92ca-3afd508032f3.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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa8bb4f45-7a1a-4bf7-92ca-3afd508032f36
198440acetaminophen 500 MG Oral TabletSCDa8bb4f45-7a1a-4bf7-92ca-3afd508032f36
198440APAP 500 MG Oral TabletSYa8bb4f45-7a1a-4bf7-92ca-3afd508032f36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4484-1118224484011 BOTTLE in 1 CARTON (11822-4484-1) / 225 TABLET in 1 BOTTLE1 bottle2020-09-082026-11-30NoNoCurrent
11822-4484-2118224484021000 TABLET in 1 BOTTLE (11822-4484-2) 1000 tablet2020-09-040000-00-00NoNoCurrent
11822-4484-3118224484031 BOTTLE in 1 CARTON (11822-4484-3) / 24 TABLET in 1 BOTTLE1 bottle2022-07-012026-10-31NoNoCurrent
11822-4484-4118224484041 BOTTLE in 1 CARTON (11822-4484-4) / 50 TABLET in 1 BOTTLE1 bottle2022-07-112026-10-31NoNoCurrent
11822-4484-5118224484051 BOTTLE in 1 CARTON (11822-4484-5) / 100 TABLET in 1 BOTTLE1 bottle2022-07-112026-12-31NoNoCurrent
11822-4484-611822448406500 TABLET in 1 BOTTLE (11822-4484-6) 500 tablet2022-07-112026-12-31NoNoCurrent