Home NDC 54838-115 Pediatric Cough and Cold Medicine
Product NDC 54838-115
11-digit product format 548380115
Labeler code 54838
Product ID 54838-115_2e6126c9-4fb1-4cd7-b5e3-449123620bbc
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide
Dosage form LIQUID
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1997-01-05
Marketing end 0000-00-00
Substance CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 1 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54838-115-40 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54838-115-40 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54838-115-40 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54838-115-40 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54838-115-40 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54838-115-40 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54838-115-40 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54838-115-40 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54838-115-40 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54838-115-40 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54838-115-40 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54838-115-40 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Chlorpheniramine maleate ACTIVE INGREDIENT V1Q0O9OJ9Z PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Chlorpheniramine ACTIVE MOIETY 3U6IO1965U PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Dextromethorphan ACTIVE MOIETY 7355X3ROTS PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 glycerin INACTIVE INGREDIENT PDC6A3C0OX PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 sorbitol INACTIVE INGREDIENT 506T60A25R PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 water INACTIVE INGREDIENT 059QF0KO0R PEDIATRIC COUGH AND COLD MEDICINE (CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-115-40 54838011540 120 mL in 1 BOTTLE, PLASTIC (54838-115-40) 120 ml 1997-01-05 0000-00-00 No No Current