Home NDC 69168-005-40 Pain Relief
Product NDC 69168-005
Requested package NDC 69168-005-40
11-digit product format 691680005
Labeler code 69168
Product ID 69168-005_88c123d3-f75c-4305-b47f-e5398ac27959
Type HUMAN OTC DRUG
Nonproprietary name Pain Relief
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-23
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69168-005 69168-005-40 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69168-005 69168-005-40 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base Pain Relief
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 69168-005-40 Pain ReliefExtra Strength 40 in 1 BOTTLE TABLET 40 3 69168-005-40 Pain ReliefExtra Strength 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-005 PAIN RELIEF EXTRA STRENGTH (PAIN RELIEF) TABLET [ALLEGIANT HEALTH] 3 Current NDC, Legacy NDC, 2 package rows 20231020_d41d2319-8eed-4df9-813c-313497ceb8b4.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 85 · 1,681 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 69168-005-40 69168000540 1 BOTTLE in 1 CARTON (69168-005-40) / 40 TABLET in 1 BOTTLE 1 bottle 2021-11-23 0000-00-00 No No Current