FDA.reportPublic FDA data

Walgreen High Blood Pressure Nighttime

Product NDC
0363-6210
11-digit product format
003636210
Labeler code
0363
Product ID
0363-6210_44e13f3b-3156-311a-e063-6294a90ae5a2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREENS CO.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-03
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
Walgreen High Blood Pressure Nighttime
Brand name suffix
Cold and Flu
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
0363-6210-08Walgreen High Blood Pressure NighttimeCold and Flu236 mL in 1 BOTTLE, PLASTICLIQUID2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6210WALGREEN HIGH BLOOD PRESSURE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [WALGREENS CO.]3Current NDC, 1 package rows20241115_f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a.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 SolutionPSNf1b7b58f-bbc3-441f-926f-d66e6a9b4e3a4
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf1b7b58f-bbc3-441f-926f-d66e6a9b4e3a4
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf1b7b58f-bbc3-441f-926f-d66e6a9b4e3a4
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf1b7b58f-bbc3-441f-926f-d66e6a9b4e3a4
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf1b7b58f-bbc3-441f-926f-d66e6a9b4e3a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6210-0800363621008236 mL in 1 BOTTLE, PLASTIC (0363-6210-08) 236 ml2023-03-03NoNoCurrent