Home NDC 0363-0019-34 Cough
Product NDC 0363-0019
Requested package NDC 0363-0019-34
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 · 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 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 0363-0019-34 00363001934 237 mL in 1 BOTTLE (0363-0019-34) 237 ml 2016-03-30 0000-00-00 No No Current