Home NDC 68998-004-04 Pain Reliever
Product NDC 68998-004
Requested package NDC 68998-004-04
11-digit product format 689980004
Labeler code 68998
Product ID 68998-004_28735d9d-6830-a776-e063-6394a90a9b8d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Marc Glassman, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-03-01
Marketing end 2027-03-31
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 Pain Reliever
Brand name suffix Extra Strength 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 68998-004-04 Pain RelieverExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 4 68998-004-04 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 4 68998-004-06 Pain RelieverExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68998-004 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MARC GLASSMAN, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20241207_43bf297f-2832-424f-a013-4bfa1d6c03e6.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 68998-004-04 68998000404 1 BOTTLE, PLASTIC in 1 CARTON (68998-004-04) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2008-03-01 2024-12-31 No No Current