Nighttime Cough Relief

Product NDC
37012-668
Requested package NDC
37012-668-40
11-digit product format
370120668
Labeler code
37012
Product ID
37012-668_6941fe97-673b-4f49-9e8f-8a001a9cbb0e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-19
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37012-66837012-668-40DDiscontinued by firm2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [SHOPKO STORES OPERATING CO., LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-668-4037012066840354 mL in 1 BOTTLE (37012-668-40) 354 ml2013-08-190000-00-00NoNoCurrent