Home NDC 0363-0419 Cough
Product NDC 0363-0419
11-digit product format 003630419
Labeler code 0363
Product ID 0363-0419_e18ebad8-a888-4400-b220-eb02cb6c5630
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Walgreen Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1993-04-09
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5 mg/5mL; mg/5mL
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-0419-26 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-0419-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-0419-26 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-0419-26 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-0419-26 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-0419-26 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-0419-26 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-0419-26 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0419-26 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-0419-26 ad56d346431e…cc804d4bbf1e…
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 CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 MALTITOL INACTIVE INGREDIENT D65DG142WK COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0419-26 00363041926 1 BOTTLE in 1 CARTON (0363-0419-26) > 118 mL in 1 BOTTLE 1 bottle 2007-08-03 0000-00-00 No No Current