FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
49483-341
11-digit product format
494830341
Labeler code
49483
Product ID
49483-341_3861fde3-66fe-f10c-e063-6394a90addc0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TIME CAP LABS INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-18
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
fd24d0e0-4f36-42d3-9149-2fb957690305Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-341-01ACETAMINOPHENExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
49483-341-10ACETAMINOPHENExtra Strength1000 in 1 BOTTLETABLET, FILM COATED10009
49483-341-20ACETAMINOPHENExtra Strength200 in 1 BOTTLETABLET, FILM COATED2009
49483-341-50ACETAMINOPHENExtra Strength500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-341-01EA - Each49483-341235679f0-0eaa-47b9-899d-63526768600312016-12-07
49483-341-10EA - Each49483-34171d67bca-8711-4a54-a736-537e8c9e887e12022-02-07
49483-341-50EA - Each49483-3412a7fd6e7-9368-4aee-9196-b0ae222c383f12021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-341ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]8Current NDC, Legacy NDC, 4 package rows20231027_fd24d0e0-4f36-42d3-9149-2fb957690305.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 18 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Enteric CoatedASPIRIN 81 MGGrocery Outlet79c64e27-87aa-4081-8cbf-343768b00b902026-03-19WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRINMAJOR PHARMACEUTICALS7c24aff7-2b96-27ac-e053-2991aa0a57142026-03-19WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENBryant Ranch Prepackea417ddb-54b3-49e2-bec1-8fe450d9990c2026-03-19WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENHyVee Inc3b08738e-cde2-4843-b609-8f12582c6d082026-03-18WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.0666f082-84f3-4041-a322-311188a156702026-03-18WarningsExact identifier
application number: M013
AMAZON BASICS ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC3c2914a4-913e-7e50-e063-6294a90aff3a2026-03-18WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackc6cec390-004e-45f6-9388-c662a979f37d2026-03-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINChain Drug Marketing Association, Inc.b32ada58-a098-47d2-9ed2-4d59186577092026-03-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWalgreen Company413b3b95-2867-4534-8290-54f477cccf1e2026-03-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCVS Pharmacyc55304be-bfc0-46a8-a37e-2e6ba90983942026-03-12WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINPreferred Pharmaceuticals Inc.1b5b8bb1-c45d-48f0-b275-9ce1f769fed42026-03-09WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
application number: M013
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfd24d0e0-4f36-42d3-9149-2fb9576903059
198440acetaminophen 500 MG Oral TabletSCDfd24d0e0-4f36-42d3-9149-2fb9576903059
198440APAP 500 MG Oral TabletSYfd24d0e0-4f36-42d3-9149-2fb9576903059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-341-0149483034101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-01) 2018-12-170000-00-00NoNoCurrent
49483-341-10494830341101000 TABLET, FILM COATED in 1 BOTTLE (49483-341-10) 2022-01-200000-00-00NoNoCurrent
49483-341-2049483034120200 TABLET, FILM COATED in 1 BOTTLE (49483-341-20) 2023-10-25NoNoCurrent
49483-341-5049483034150500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-50) 2021-05-200000-00-00NoNoCurrent