FDA.reportPublic FDA data

good sense night time

Product NDC
0113-0056
11-digit product format
001130056
Labeler code
0113
Product ID
0113-0056_fea7bdc4-66c7-4a30-8128-7f2a0d2d609c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
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 night time
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1094549

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
0113-0056-51good sense night time4 in 1 CARTONCAPSULE, LIQUID FILLED48
0113-0056-51good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-62good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-62good sense night time12 in 1 CARTONCAPSULE, LIQUID FILLED128
0113-0056-67good sense night time24 in 1 CARTONCAPSULE, LIQUID FILLED248
0113-0056-67good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-73good sense night time8 in 1 CARTONCAPSULE, LIQUID FILLED88
0113-0056-73good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0056-51EA - Each0113-0056d80b7088-2fd9-4cc5-bd73-85ffa53a6ee812018-02-20
0113-0056-62EA - Each0113-00566a797dff-9ec1-4629-9a90-89043f3b3efa12021-07-15
0113-0056-73EA - Each0113-005677c4dcde-a68d-4782-9dbe-33fda7e914d712021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0056GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 8 package rows20241018_e47dffdf-5778-4804-8ce2-54c5a72bba3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNe47dffdf-5778-4804-8ce2-54c5a72bba3a8
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDe47dffdf-5778-4804-8ce2-54c5a72bba3a8
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYe47dffdf-5778-4804-8ce2-54c5a72bba3a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0056-51001130056514 BLISTER PACK in 1 CARTON (0113-0056-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2016-08-100000-00-00NoNoCurrent
0113-0056-620011300566212 BLISTER PACK in 1 CARTON (0113-0056-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2014-08-250000-00-00NoNoCurrent
0113-0056-670011300566724 BLISTER PACK in 1 CARTON (0113-0056-67) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2026-01-08NoNoHistorical
0113-0056-73001130056738 BLISTER PACK in 1 CARTON (0113-0056-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2014-05-300000-00-00NoNoCurrent