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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact 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