Home NDC 69848-003 Acetaminophen
Product NDC 69848-003
11-digit product format 698480003
Labeler code 69848
Product ID 69848-003_468e5f4e-8bc6-6b97-e063-6294a90a0166
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Granules USA, Inc
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 69848-003-10 excluded package package 69848-003-24 excluded package package 69848-003-17
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
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69848-003-10 2020-12-30 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-17 2020-12-30 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-24 2020-12-30 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-10 2020-09-27 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-17 2020-09-27 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-24 2020-09-27 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-10 2020-09-25 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-17 2020-09-25 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-24 2020-09-25 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-10 2020-07-22 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-17 2020-07-22 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS 69848-003-24 2020-07-22 EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69848-003-10 Acetaminophen 100 in 1 BOTTLE TABLET 100 8 69848-003-17 Acetaminophen 175 in 1 BOTTLE TABLET 175 8 69848-003-24 Acetaminophen 24 in 1 BOTTLE TABLET 24 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69848-003 ACETAMINOPHEN TABLET [GRANULES USA, INC] 7 Current NDC, Legacy NDC, 3 package rows 20241218_a1255f60-b9c6-9a95-e053-2995a90a9e80.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 13 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69848-003-10 69848000310 100 TABLET in 1 BOTTLE (69848-003-10) 100 tablet 2019-07-01 0000-00-00 No No Current 69848-003-17 69848000317 175 TABLET in 1 BOTTLE (69848-003-17) 175 tablet 2019-07-01 0000-00-00 No No Current 69848-003-24 69848000324 24 TABLET in 1 BOTTLE (69848-003-24) 24 tablet 2019-07-01 0000-00-00 No No Current