Home NDC 54838-125-40 Brotapp
Product NDC 54838-125
Requested package NDC 54838-125-40
11-digit product format 548380125
Labeler code 54838
Product ID 54838-125_359f98a1-f1bc-42c0-89c1-a5e7e4d64999
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate and Pseudoephedrine hydrochloride
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
Active strength 1 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 (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 Pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 Brompheniramine ACTIVE MOIETY H57G17P2FN BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 sorbitol INACTIVE INGREDIENT 506T60A25R BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16 water INACTIVE INGREDIENT 059QF0KO0R BROTAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 16
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-125-40 54838012540 118 mL in 1 BOTTLE, PLASTIC (54838-125-40) 118 ml 2001-04-05 0000-00-00 No No Current