Cough

Product NDC
0363-0500
11-digit product format
003630500
Labeler code
0363
Product ID
0363-0500_7460410b-aff3-4aae-9724-438d1dd13b2b
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-20
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/15mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-0500DDiscontinued by firm2026-08-11
excluded packagepackage0363-05000363-0500-40DDiscontinued by firm2026-08-11

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0500-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0500-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0500-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0500-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0500-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0500-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0500-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0500-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0500-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0500-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0500-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0500-40557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH (DEXTROMETHORPHAN HBR) LIQUID [WALGREEN COMPANY]1