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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
application number: M013
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
application number: M013
Meijer Effervescent Pain ReliefASPIRINMeijer Distribution Inc17553911-e0fc-e355-e063-6394a90af7b82024-06-28WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsExact identifier
application number: M013
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsExact identifier
application number: M013
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
application number: M013
AspirinREGULAR STRENGTH ENTERIC COATED ASPIRINNuCare Pharmceuticals,Inc.a0705f4f-55cb-214a-e053-2995a90aa6802024-06-20WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRETAIL BUSINESS SERVICES , LLC.093182a6-3ed8-5a3f-e063-6294a90a354a2024-06-14WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact 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