Home NDC 70010-161 ACETAMINOPHEN
Product NDC 70010-161
11-digit product format 700100161
Labeler code 70010
Product ID 70010-161_31c4de05-74c3-ddc3-e063-6394a90a9388
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-15
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70010-161-01 ACETAMINOPHEN 1 in 1 CARTON TABLET 1 5 70010-161-01 ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 5 70010-161-05 ACETAMINOPHEN 500 in 1 BOTTLE TABLET 500 5 70010-161-10 ACETAMINOPHEN 1000 in 1 BOTTLE TABLET 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70010-161 ACETAMINOPHEN TABLET [GRANULES PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250406_d5d49146-665e-4a93-e053-2995a90aca59.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 Units Marketing start Marketing end Sample Exclude flag Status 70010-161-01 70010016101 1 BOTTLE in 1 CARTON (70010-161-01) / 100 TABLET in 1 BOTTLE 1 bottle 2022-02-15 0000-00-00 No No Current 70010-161-05 70010016105 500 TABLET in 1 BOTTLE (70010-161-05) 500 tablet 2022-02-15 0000-00-00 No No Current 70010-161-10 70010016110 1000 TABLET in 1 BOTTLE (70010-161-10) 1000 tablet 2022-02-15 No No Current