Home NDC 69036-120 LORTUSS
Product NDC 69036-120
11-digit product format 690360120
Labeler code 69036
Product ID 69036-120_41999ae8-18fc-49a0-a55c-ffa00f353ddd
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Sallus Laboratories, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-06-14
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 15 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 · 26 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 69036-120-16 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 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LORTUSS DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SALLUS LABORATORIES, LLC] 2