Home NDC 54859-010 Dologesic
Product NDC 54859-010
11-digit product format 548590010
Labeler code 54859
Product ID 54859-010_47460679-895e-b4d5-e063-6394a90ab919
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dexbrompheniramine Maleate
Dosage form TABLET
Route ORAL
Labeler Llorens Pharmaceutical International Division
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-01
Substance ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength 500; 1 mg/1; 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54859-010-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54859-010-01 9bebd1f3094a…5416666fcb17…
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 Dologesic
Brand name suffix DF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DEXBROMPHENIRAMINE MALEATE 1 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 BPA9UT29BS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1798453 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 54859-010-01 DologesicDF 100 in 1 BOTTLE TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-010 DOLOGESIC DF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 6 Current NDC, Legacy NDC, 1 package rows 20241225_55768b45-fd98-4779-85b6-6a50c628677e.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 74 of 180 · 3,583 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 54859-010-01 54859001001 100 TABLET in 1 BOTTLE (54859-010-01) 100 tablet 2016-04-01 0000-00-00 No No Current