Home NDC 54859-802 Conex
Product NDC 54859-802
11-digit product format 548590802
Labeler code 54859
Product ID 54859-802_0b13510e-96ea-481c-9013-ff68716ac472
Type HUMAN OTC DRUG
Nonproprietary name Dexbrompheniramine Maleate, Pseudoephedrine
Dosage form LIQUID
Route ORAL
Labeler Llorens Pharmaceutical International Division
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-11-01
Marketing end 0000-00-00
Substance DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 1 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product E Excluded after deficient or non-compliant submission was not corrected f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product E Excluded after deficient or non-compliant submission was not corrected 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product E Excluded after deficient or non-compliant submission was not corrected a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product E Excluded after deficient or non-compliant submission was not corrected cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54859-802-16 E Excluded after deficient or non-compliant submission was not corrected cdf11ea48f46…ba0047e9e063…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54859-802-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54859-802-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 54859-802-16 Conex 473 mL in 1 BOTTLE LIQUID 473 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXBROMPHENIRAMINE MALEATE ACTIVE INGREDIENT BPA9UT29BS CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 DEXBROMPHENIRAMINE ACTIVE MOIETY 75T64B71RP CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-802 CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 8 Legacy NDC, 1 package rows 20241228_c564e4f2-7d11-4f3e-aff2-35755fbe7d55.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54859-802-04 54859080204 118 mL in 1 BOTTLE (54859-802-04) 118 ml 2007-11-01 0000-00-00 No No Current 54859-802-16 54859080216 473 mL in 1 BOTTLE 473 ml Historical