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 firm2026-10-16

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 9 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
application number: M013
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINFamora Inc.4dc6f119-bbde-db5f-e063-6294a90a94862026-06-16WarningsExact identifier
application number: M013
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
application number: M013
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
application number: M013
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact 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