Home NDC 49483-430-40 Extra strength Acetaminophen PM
Product NDC 49483-430
Requested package NDC 49483-430-40
11-digit product format 494830430
Labeler code 49483
Product ID 49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg/ Diphenhydramine HCl 25mg
Dosage form TABLET
Route ORAL
Labeler TIME CAP LABS INC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-22
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 49483-430 49483-430-40 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 49483-430 49483-430-40 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 49483-430 49483-430-40 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Extra strength Acetaminophen PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 500 mg/1 ACETAMINOPHEN 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup 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 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 49483-430-40 Extra strength Acetaminophen PM 400 in 1 BOTTLE TABLET 400 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-430 EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG) TABLET [TIME CAP LABS INC] 2 Current NDC, 1 package rows 20250212_010c5c98-fc67-a9c3-e063-6394a90aa640.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 Sample Exclude flag Status 49483-430-40 49483043040 400 TABLET in 1 BOTTLE (49483-430-40) 400 tablet 2023-07-22 No No Current