Night Time Cold/Flu Relief Original

Product NDC
67510-1501
11-digit product format
675101501
Labeler code
67510
Product ID
67510-1501_489bf408-8a99-488b-b6ec-3901d8e9b3b5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Kareway Product, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-1501-02019-11-13C16284748780-197449f38-c6ec-f6ea-e053-dbdaa90aa703Drug Facts
67510-1501-22019-11-13C16284748780-197449f38-c6ec-f6ea-e053-dbdaa90aa703Drug Facts
67510-1501-42019-11-13C16284748780-197449f38-c6ec-f6ea-e053-dbdaa90aa703Drug Facts
67510-1501-62019-11-13C16284748780-197449f38-c6ec-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-1501-0Night Time Cold/Flu Relief Original295 mL in 1 BOTTLELIQUID2951
67510-1501-2Night Time Cold/Flu Relief Original354 mL in 1 BOTTLELIQUID3541
67510-1501-4Night Time Cold/Flu Relief Original120 mL in 1 BOTTLELIQUID1201
67510-1501-6Night Time Cold/Flu Relief Original177 mL in 1 BOTTLELIQUID1771

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554NIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-1501NIGHT TIME COLD/FLU RELIEF ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]1Legacy NDC, 4 package rows20120731_be51f707-ec9d-47dc-a2fc-9cdc83600b6a.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 SolutionPSNbe51f707-ec9d-47dc-a2fc-9cdc83600b6a1
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDbe51f707-ec9d-47dc-a2fc-9cdc83600b6a1
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYbe51f707-ec9d-47dc-a2fc-9cdc83600b6a1
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYbe51f707-ec9d-47dc-a2fc-9cdc83600b6a1
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYbe51f707-ec9d-47dc-a2fc-9cdc83600b6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67510-1501-067510150100295 mL in 1 BOTTLE295 mlHistorical
67510-1501-267510150102354 mL in 1 BOTTLE354 mlHistorical
67510-1501-467510150104120 mL in 1 BOTTLE120 mlHistorical
67510-1501-667510150106177 mL in 1 BOTTLE177 mlHistorical