ACETAMINOPHEN

Product NDC
49035-869
11-digit product format
490350869
Labeler code
49035
Product ID
49035-869_2b6bd14c-185b-865b-e063-6394a90a5dad
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WAL-MART STORES INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-869DDiscontinued by firm2026-10-12
excluded packagepackage49035-86949035-869-21DDiscontinued by firm2026-10-12

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-869-21DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-869-21DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-869-21DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-869-21DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-869-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-869-21DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-869-21DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-869-21DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-869-50UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-869-21DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-869-50UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-869-21DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-869-21DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-869-21DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

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
2026-12-31

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
a354b24e-0913-829f-e053-2995a90ad407Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-869-50ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-869-50EA - Each49035-86932da6c1c-7f36-4b6d-946f-7c066f2a743d12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-869ACETAMINOPHEN TABLET, COATED [WAL-MART STORES INC]3Current NDC, 1 package rows20250121_a354b24e-0913-829f-e053-2995a90ad407.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 12 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutions92559d65-f5e2-4054-9763-b9c560452dab2026-05-22WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.441d2629-3fff-0bf1-e063-6394a90aa9b62026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d1bde-d677-fab7-e063-6394a90aaad42026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d3a39-cc55-3c7c-e063-6394a90ad7a72026-05-21WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
application number: M013
Good Sense aspirinASPIRINL. Perrigo Companye150dd59-8db8-449f-9c9a-1aa6deb3be2e2026-05-20WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLCe837538d-0515-4f99-b04c-fda63b28777e2026-05-20WarningsExact identifier
application number: M013
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.5220a40d-4a4f-5bad-e063-6394a90a93b02026-05-18WarningsExact identifier
application number: M013
childrens Pain and FeverACETAMINOPHENTopco Associates, LLC7f7b4377-9b40-4a12-808b-f1cd7d241b0d2026-05-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINGendose Pharmaceuticals, LLC10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa2026-05-15WarningsExact identifier
application number: M013
AspirinASPIRINGendose Pharmaceuticals, LLC119de26f-cce5-401c-81fa-775ebebf6c6f2026-05-15WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINCardinal Health 107, LLC827bbe77-febb-4352-892f-3fbb2acfc7d52026-05-14WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC56c125de-fabf-41fa-88a4-760d2793f2022026-05-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEChain Drug Marketing Association, Inc.17216bf3-bed0-4d7a-994e-76a0e4c79c5c2026-05-13WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutionsc445c6bb-69a8-492e-b100-ce942707f2032026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Company1754a9f2-e7e5-4efb-a728-6ba2a7155d112026-05-12WarningsExact identifier
application number: M013
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATETarget Corporationbc65e205-64fd-4764-8c5e-2793af4e9adf2026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLCa7e27000-a26b-46c2-823e-663f4e76db742026-05-11WarningsExact identifier
application number: M013
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa354b24e-0913-829f-e053-2995a90ad4073
198440acetaminophen 500 MG Oral TabletSCDa354b24e-0913-829f-e053-2995a90ad4073
198440APAP 500 MG Oral TabletSYa354b24e-0913-829f-e053-2995a90ad4073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
49035-869-5049035086950500 TABLET, COATED in 1 BOTTLE (49035-869-50) 2020-06-01NoNoCurrent