Home NDC 69676-0063-5 Genexa Acetaminophen PM
Product NDC 69676-0063
Requested package NDC 69676-0063-5
11-digit product format 696760063
Labeler code 69676
Product ID 69676-0063_2e9472c4-b466-e4fd-e063-6394a90ad2f6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Genexa Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-17
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 · 3 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69676-0063 69676-0063-5 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69676-0063 69676-0063-5 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69676-0063 69676-0063-5 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Genexa Acetaminophen PM
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69676-0063-2 Genexa Acetaminophen PMExtra Strength 100 in 1 BOTTLE TABLET, COATED 100 5 69676-0063-2 Genexa Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 69676-0063-5 Genexa Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 69676-0063-5 Genexa Acetaminophen PMExtra Strength 50 in 1 BOTTLE TABLET, COATED 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0063 GENEXA ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [GENEXA INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250228_d82cf6f3-a291-ca2b-e053-2a95a90a6de1.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 84 · 1,678 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 69676-0063-5 69676006305 1 BOTTLE in 1 CARTON (69676-0063-5) / 50 TABLET, COATED in 1 BOTTLE 1 bottle 2022-02-17 0000-00-00 No No Current