Good Sense Nighttime Cough

Product NDC
0113-0668
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

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
0113-0668-3400113066834237 mL in 1 BOTTLE (0113-0668-34) 237 ml2012-09-120000-00-00NoNoCurrent
0113-0668-4000113066840354 mL in 1 BOTTLE (0113-0668-40) 354 ml2022-02-010000-00-00NoNoCurrent