Acetaminophen

Product NDC
41163-500
11-digit product format
411630500
Labeler code
41163
Product ID
41163-500_24b0d399-5710-8baf-e063-6394a90aa1a5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-50041163-500-02DDiscontinued by firm2026-10-15
excluded packagepackage41163-50041163-500-05DDiscontinued by firm2026-10-15
excluded packagepackage41163-50041163-500-17DDiscontinued 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 · 36 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 2025-12-0541163-500-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-500-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-500-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641163-500-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-500-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-500-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141163-500-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-500-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-500-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841163-500-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-500-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-500-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141163-500-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-500-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-500-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041163-500-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-500-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-500-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141163-500-17302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-500-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-500-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041163-500-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-500-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-500-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041163-500-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-500-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-500-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841163-500-17ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-500-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-500-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341163-500-17367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-500-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-500-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941163-500-17557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-500-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-500-02557ba5c1ecfa…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
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
f3db8598-fe0e-4c53-a023-5f5f8f002cc6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-500-01AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-01AcetaminophenExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED247
41163-500-02AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-02AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED507
41163-500-04AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-04AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1007
41163-500-05AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-05AcetaminophenExtra Strength250 in 1 BOTTLE, PLASTICTABLET, COATED2507
41163-500-06AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-06AcetaminophenExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5007
41163-500-17AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-17AcetaminophenExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED1507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-500-01EA - Each41163-5000542addf-a02a-45b0-8a77-7783fffc3d7312016-10-06
41163-500-04EA - Each41163-50072c2c122-7bbb-4568-a416-72e343402b0212016-06-14
41163-500-05EA - Each41163-5000acacb01-4dc9-4044-a453-22324f44f44112016-10-06
41163-500-06EA - Each41163-5002dd86359-09a8-49cb-a882-ebe40b927df912016-10-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-500ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 12 package rows20241019_f3db8598-fe0e-4c53-a023-5f5f8f002cc6.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 5 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY258975d2-d8e8-407d-9804-df3b37a184e42026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINCardinal Health 107, LLC277723db-3578-4842-92eb-2de325f876492026-07-28WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf3db8598-fe0e-4c53-a023-5f5f8f002cc67
198440acetaminophen 500 MG Oral TabletSCDf3db8598-fe0e-4c53-a023-5f5f8f002cc67
198440APAP 500 MG Oral TabletSYf3db8598-fe0e-4c53-a023-5f5f8f002cc67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-500-01411630500011 BOTTLE, PLASTIC in 1 CARTON (41163-500-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-02411630500021 in 1 CARTONHistorical
41163-500-04411630500041 BOTTLE, PLASTIC in 1 CARTON (41163-500-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-05411630500051 in 1 CARTONHistorical
41163-500-06411630500061 BOTTLE, PLASTIC in 1 CARTON (41163-500-06) / 500 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-17411630500171 in 1 CARTONHistorical