Home NDC 49580-0345-4 Nighttime Cough
Product NDC 49580-0345
Requested package NDC 49580-0345-4
11-digit product format 495800345
Labeler code 49580
Product ID 49580-0345_c4a092d8-7292-4cfe-8ab7-df1e8b3e3170
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-07-31
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 30 mg/30mL; mg/30mL
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 · 9 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…
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 NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHTTIME COUGH ALL NIGHT COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49580-0345-4 49580034504 118 mL in 1 BOTTLE (49580-0345-4) 118 ml 2014-07-31 0000-00-00 No No Current