Night Time Cold and Flu Relief

Product NDC
0904-6996
11-digit product format
009046996
Labeler code
0904
Product ID
0904-6996_f90b7074-639a-41ea-a6a4-e7d2cd5243fe
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-30
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
Night Time Cold and Flu Relief
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
0904-6996-44Night Time Cold and Flu Relief16 in 1 CARTONCAPSULE, LIQUID FILLED165
0904-6996-44Night Time Cold and Flu Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6996-44EA - Each0904-69969cd2137b-b804-4066-b568-0ad228ddc7ff12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6996NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250112_f81efbf4-204b-45be-ae32-910d9e4ae4aa.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 CapsulePSNf81efbf4-204b-45be-ae32-910d9e4ae4aa5
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDf81efbf4-204b-45be-ae32-910d9e4ae4aa5
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYf81efbf4-204b-45be-ae32-910d9e4ae4aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6996-440090469964416 BLISTER PACK in 1 CARTON (0904-6996-44) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK16 blister pack2019-09-300000-00-00NoNoCurrent