Home NDC 58605-153 BroveX PEB DM
Product NDC 58605-153
11-digit product format 586050153
Labeler code 58605
Product ID 58605-153_6c2d7ce5-af0f-4a67-af49-ebe16e165dd4
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form LIQUID
Route ORAL
Labeler MCR American Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-11-30
Marketing end 0000-00-00
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 4 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 39 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58605-153-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58605-153-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58605-153-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58605-153-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58605-153-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58605-153-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58605-153-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58605-153-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58605-153-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58605-153-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58605-153-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58605-153-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58605-153-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58605-153-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58605-153-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58605-153-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58605-153-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58605-153-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58605-153-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58605-153-02 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58605-153-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58605-153-02 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58605-153-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58605-153-02 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58605-153-01 I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58605-153-02 I Inactivated by FDA 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Brompheniramine Maleate ACTIVE INGREDIENT IXA7C9ZN03 BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Brompheniramine ACTIVE MOIETY H57G17P2FN BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Potassium Citrate INACTIVE INGREDIENT EE90ONI6FF BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Potassium Sorbate INACTIVE INGREDIENT 1VPU26JZZ4 BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R BROVEX PEB DM (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.] 1