FDA.reportPublic FDA data

good sense nighttime

Product NDC
0113-0459
11-digit product format
001130459
Labeler code
0113
Product ID
0113-0459_0add9786-62cc-4ad4-8487-d61c84db9d3b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-22
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0459-30good sense nighttime177 mL in 1 BOTTLESOLUTION17710
0113-0459-34good sense nighttime237 mL in 1 BOTTLESOLUTION23710
0113-0459-38good sense nighttime296 mL in 1 BOTTLESOLUTION29610
0113-0459-40good sense nighttime354 mL in 1 BOTTLESOLUTION35410
0113-0459-40GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME354 mL in 1 BOTTLESOLUTION354 mL650 mg in 30mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0459-30ML - Milliliter0113-04597db2ac14-75c2-422a-b2fc-22f23175851d12012-07-24
0113-0459-34ML - Milliliter0113-0459040c17e7-69bd-4ad1-b9eb-ce871210501c12018-02-20
0113-0459-38ML - Milliliter0113-045910347002-1247-4a76-8961-8061a825e73c12012-07-24
0113-0459-40ML - Milliliter0113-0459ad907d4a-63e6-4555-901d-96c14ad1579b12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2GOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0459GOOD SENSE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 4 package rows20241027_f90bd64a-dd1a-4319-87cd-427d57f677ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNf90bd64a-dd1a-4319-87cd-427d57f677ab10
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf90bd64a-dd1a-4319-87cd-427d57f677ab10
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf90bd64a-dd1a-4319-87cd-427d57f677ab10
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf90bd64a-dd1a-4319-87cd-427d57f677ab10
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf90bd64a-dd1a-4319-87cd-427d57f677ab10
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCKd25f2649-4f8a-4339-8443-faa0b98bdd701
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSNd25f2649-4f8a-4339-8443-faa0b98bdd701
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNd25f2649-4f8a-4339-8443-faa0b98bdd701
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNd25f2649-4f8a-4339-8443-faa0b98bdd701
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDd25f2649-4f8a-4339-8443-faa0b98bdd701
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDd25f2649-4f8a-4339-8443-faa0b98bdd701
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYd25f2649-4f8a-4339-8443-faa0b98bdd701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0459-3000113045930177 mL in 1 BOTTLE (0113-0459-30) 177 ml2011-09-120000-00-00NoNoCurrent
0113-0459-3400113045934237 mL in 1 BOTTLE (0113-0459-34) 237 ml2012-07-270000-00-00NoNoCurrent
0113-0459-3800113045938296 mL in 1 BOTTLE (0113-0459-38) 296 ml2011-08-220000-00-00NoNoCurrent
0113-0459-4000113045940354 mL in 1 BOTTLE (0113-0459-40) 354 ml2012-08-310000-00-00NoNoCurrent