Home NDC 49483-341 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 Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-341-01 ACETAMINOPHENExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 9 49483-341-10 ACETAMINOPHENExtra Strength 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9 49483-341-20 ACETAMINOPHENExtra Strength 200 in 1 BOTTLE TABLET, FILM COATED 200 9 49483-341-50 ACETAMINOPHENExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-341 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC] 8 Current NDC, Legacy NDC, 4 package rows 20231027_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 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-341-01 49483034101 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-01) 2018-12-17 0000-00-00 No No Current 49483-341-10 49483034110 1000 TABLET, FILM COATED in 1 BOTTLE (49483-341-10) 2022-01-20 0000-00-00 No No Current 49483-341-20 49483034120 200 TABLET, FILM COATED in 1 BOTTLE (49483-341-20) 2023-10-25 No No Current 49483-341-50 49483034150 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-50) 2021-05-20 0000-00-00 No No Current