Good Sense Nighttime Cough

Product NDC
0113-0668
Requested package NDC
0113-0668-30
11-digit product format
001130668
Labeler code
0113
Product ID
0113-0668_3865028d-6ece-4633-aa41-a248cd171b4e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2002-11-03
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

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 packagepackage0113-06680113-0668-30DDiscontinued 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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0668-30ML - Milliliter0113-0668b05afa09-93e7-4093-b3d7-46f6b690958012012-07-24
0113-0668-34ML - Milliliter0113-0668303409c1-2a3f-454f-80f8-4b3ce374f05c12018-02-20
0113-0668-40ML - Milliliter0113-0668d1a131b5-9dd7-4690-a9a2-94b2ddccf3cd12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2GOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [L. PERRIGO COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0668GOOD SENSE NIGHTTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]9Legacy NDC20241024_f7d380ba-66bf-43cc-8b08-070bfe20af80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0668-3000113066830177 mL in 1 BOTTLE (0113-0668-30) 177 ml2002-11-030000-00-00NoNoCurrent