Nite-TimeCOLD/FLU CHERRY

Product NDC
57243-502
11-digit product format
572430502
Labeler code
57243
Product ID
57243-502_21dee833-1f0b-4ac7-a662-169dc2fc6d0a
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
LIQUID
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nite-TimeCOLD/FLU CHERRY
Brand name suffix
COLD/FLU CHERRY
Listing expiration
2026-12-31

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
57243-502-25Nite-TimeCOLD/FLU CHERRYCOLD/FLU CHERRY177 mL in 1 BOTTLELIQUID1778

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RNITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-502NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]8Current NDC, Legacy NDC, 1 package rows20231230_e6c3e545-b2ad-47f0-8318-c134a8e24f5b.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 SolutionPSNe6c3e545-b2ad-47f0-8318-c134a8e24f5b8
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe6c3e545-b2ad-47f0-8318-c134a8e24f5b8
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe6c3e545-b2ad-47f0-8318-c134a8e24f5b8
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe6c3e545-b2ad-47f0-8318-c134a8e24f5b8
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe6c3e545-b2ad-47f0-8318-c134a8e24f5b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-502-2557243050225177 mL in 1 BOTTLE (57243-502-25) 177 ml2012-01-310000-00-00NoNoCurrent