FDA.reportPublic FDA data

nite time

Product NDC
30142-459
Requested package NDC
30142-459-40
11-digit product format
301420459
Labeler code
30142
Product ID
30142-459_9547c050-3a55-4ec3-bb31-e182aa69ff63
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-26
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage30142-45930142-459-40DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-459-30NightTime177 mL in 1 BOTTLESOLUTION17710
30142-459-34NightTime237 mL in 1 BOTTLESOLUTION23710
30142-459-38NightTime295 mL in 1 BOTTLESOLUTION29510
30142-459-40NightTime354 mL in 1 BOTTLESOLUTION35410

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
WATERINACTIVE INGREDIENT059QF0KO0RNITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SUCROSEINACTIVE INGREDIENTC151H8M554NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-459NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]10Legacy NDC, 4 package rows20241027_5aa3ba10-6561-4685-9ad7-1badd318ddc0.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 SolutionPSN5aa3ba10-6561-4685-9ad7-1badd318ddc010
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD5aa3ba10-6561-4685-9ad7-1badd318ddc010
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY5aa3ba10-6561-4685-9ad7-1badd318ddc010
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY5aa3ba10-6561-4685-9ad7-1badd318ddc010
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY5aa3ba10-6561-4685-9ad7-1badd318ddc010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-459-4030142045940354 mL in 1 BOTTLE (30142-459-40) 354 ml2013-08-130000-00-00NoNoCurrent