Home NDC 54838-136-40 Brotapp DM Cold and Cough
Product NDC 54838-136
Requested package NDC 54838-136-40
11-digit product format 548380136
Labeler code 54838
Product ID 54838-136_d31e3f51-016c-47a9-90ab-040bd0c10374
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine 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 2001-04-05
Marketing end 0000-00-00
Substance BROMPHENIRAMINE 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 Brompheniramine maleate ACTIVE INGREDIENT IXA7C9ZN03 BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 Dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 Pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 Brompheniramine ACTIVE MOIETY H57G17P2FN BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 Dextromethorphan ACTIVE MOIETY 7355X3ROTS BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 glycerin INACTIVE INGREDIENT PDC6A3C0OX BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 sorbitol INACTIVE INGREDIENT 506T60A25R BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13 water INACTIVE INGREDIENT 059QF0KO0R BROTAPP DM COLD AND COUGH (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-136-40 54838013640 118 mL in 1 BOTTLE, PLASTIC (54838-136-40) 118 ml 2001-04-05 0000-00-00 No No Current