FDA.reportPublic FDA data

Nighttime Cold and Flu

Product NDC
81660-777
11-digit product format
816600777
Labeler code
81660
Product ID
81660-777_494e38ca-85f0-abf1-e063-6294a90a36e5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan, Doxylamine succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Grimann, S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-11
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
Nighttime Cold and Flu
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
81660-777-01Nighttime Cold and Flu30 mL in 1 BOTTLE, PLASTICLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81660-777NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) LIQUID NIGHTTIME COLD AND FLU LIQUID CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) LIQUID [GRIMANN, S.A. DE C.V.]5Current NDC, 1 package rows20240208_fe2dd0d7-36ff-154e-e053-6394a90a88d4.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 SolutionPSNfe2dd0d7-36ff-154e-e053-6394a90a88d46
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDfe2dd0d7-36ff-154e-e053-6394a90a88d46
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYfe2dd0d7-36ff-154e-e053-6394a90a88d46
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYfe2dd0d7-36ff-154e-e053-6394a90a88d46
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYfe2dd0d7-36ff-154e-e053-6394a90a88d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81660-777-018166007770130 mL in 1 BOTTLE, PLASTIC (81660-777-01) 30 ml2023-04-11NoNoHistorical