Home NDC 0363-0019-40 Cough
Product NDC 0363-0019
Requested package NDC 0363-0019-40
11-digit product format 003630019
Labeler code 0363
Product ID 0363-0019_3bed4a6b-3e6e-47f9-89cd-cd97e28eadf6
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler Walgreen Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-02-10
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 30 mg/30mL; mg/30mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-0019 0363-0019-40 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-0019 0363-0019-40 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREEN COMPANY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0019 COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] 6 Legacy NDC 20241024_7370a23a-2d20-4dfb-8cd8-80e22013bf23.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0019-40 00363001940 355 mL in 1 BOTTLE (0363-0019-40) 355 ml 2016-03-30 0000-00-00 No No Current