FDA.reportPublic FDA data

childrens cold and cough relief dm

Product NDC
0363-3611
11-digit product format
003633611
Labeler code
0363
Product ID
0363-3611_c951cebc-bf51-464a-b2c1-2328791c4051
Type
HUMAN OTC DRUG
Nonproprietary name
brompheniramine maleate, dextromethorphan hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-04
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 10 mg/10mL; mg/10mL
Pharmacologic classes
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
childrens cold and cough relief dm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH
Rxcui2683421

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3611-26childrens cold and cough relief dm118 mL in 1 BOTTLESOLUTION1183
0363-3611-26childrens cold and cough relief dm1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3611CHILDRENS COLD AND COUGH RELIEF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [WALGREEN COMPANY]2Current NDC, 2 package rows20250412_6c7c950d-ed48-4428-9e9e-73684cabc699.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN6c7c950d-ed48-4428-9e9e-73684cabc6993
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD6c7c950d-ed48-4428-9e9e-73684cabc6993
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY6c7c950d-ed48-4428-9e9e-73684cabc6993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-3611-26003633611261 BOTTLE in 1 CARTON (0363-3611-26) / 118 mL in 1 BOTTLE1 bottle2025-04-04NoNoHistorical