Acetaminophen

Product NDC
49035-175
11-digit product format
490350175
Labeler code
49035
Product ID
49035-175_457f2649-8526-4144-baf1-cd1347417604
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-04-02
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage49035-17549035-175-10DDiscontinued by firm2026-10-12
excluded packagepackage49035-17549035-175-96DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549035-175-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549035-175-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649035-175-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649035-175-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149035-175-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149035-175-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849035-175-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849035-175-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149035-175-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149035-175-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049035-175-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049035-175-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149035-175-96302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149035-175-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049035-175-96ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049035-175-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049035-175-960efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049035-175-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849035-175-96ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849035-175-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349035-175-96367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349035-175-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949035-175-96557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949035-175-10557ba5c1ecfa…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
Brand name suffix
Extra Strength
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
78874258-16cc-40b5-9e15-5943eddfce94Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-175-10AcetaminophenExtra Strength40 in 1 BOTTLETABLET, FILM COATED4017
49035-175-10AcetaminophenExtra Strength1 in 1 CARTONTABLET, FILM COATED117
49035-175-15AcetaminophenExtra Strength1 in 1 CARTONTABLET, FILM COATED117
49035-175-15AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5017
49035-175-96AcetaminophenExtra Strength1 in 1 CARTONTABLET, FILM COATED117
49035-175-96AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-175-12EA - Each49035-175b3bf33d2-ce4d-49dc-95f1-460d430e7dfe12014-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-175ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]15Current NDC, Legacy NDC, 6 package rows20240825_78874258-16cc-40b5-9e15-5943eddfce94.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 TabletPSN78874258-16cc-40b5-9e15-5943eddfce9417
198440acetaminophen 500 MG Oral TabletSCD78874258-16cc-40b5-9e15-5943eddfce9417
198440APAP 500 MG Oral TabletSY78874258-16cc-40b5-9e15-5943eddfce9417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-175-104903501751040 in 1 BOTTLEHistorical
49035-175-15490350175151 BOTTLE, PLASTIC in 1 CARTON (49035-175-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
49035-175-96490350175961 in 1 CARTONHistorical