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 70 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN, AND CAFFEINE JHK Inc dba American Safety & First Aid 87c5ad71-0448-4e0f-acee-bf9a1d38675e 2024-04-25 Warnings Exact identifier application number: M013 dg health childrens pain and fever ACETAMINOPHEN Dolgencorp Inc 49b2ac72-86a3-4783-bf51-8c1a222e457e 2024-04-25 Warnings Exact identifier application number: M013 basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC dab1f9e6-3875-4d53-a417-c6a78274ee56 2024-04-23 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC a71074a6-cc19-4bb3-8c84-4e82a8906801 2024-04-22 Warnings Exact identifier application number: M013 Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Exact identifier application number: M013 Regular Strength Aspirin 325 mg ASPIRIN Kroger 0fc3193d-af4e-ff3a-e063-6294a90a2743 2024-04-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Exact identifier application number: M013 aspirin low dose chewable ASPIRIN Time-Cap Labs, Inc 5d56618c-8ea2-42ea-a9f2-339bd0055ddd 2024-04-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN P & L Development, LLC 0058175f-3474-40c3-a046-6cfaec86d84b 2024-04-16 Warnings Exact identifier application number: M013 Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Navajo Manufacturing Company Inc. e5481abe-6971-2bc5-e053-2995a90ae895 2024-04-15 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Exact identifier application number: M013 infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Exact identifier application number: M013 Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 Warnings Exact identifier application number: M013 Mommys Bliss Infants Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 05e26650-81b3-d7b1-e063-6394a90a14ed 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief CHILDRENS PAIN RELIEF Allegiant Health 7381dd26-c507-4d02-b989-cfd96e02f495 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief Dye-Free ACTEAMINOPHEN WinCo Foods, LLC 5ee134b3-b8e9-4621-b0a1-a84d9867ccba 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN WALGREENS 0b1d086f-7be1-5072-e063-6394a90a11e6 2024-04-10 Warnings Exact identifier application number: M013
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