FDA.reportPublic FDA data

Nighttime Cough

Product NDC
0363-4990
11-digit product format
003634990
Labeler code
0363
Product ID
0363-4990_834db720-103e-4bf6-87ee-ac46d15fb056
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 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 Cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, V9BI9B5YI2
Rxcui1234386

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4990-12Nighttime Cough355 mL in 1 BOTTLE, PLASTICLIQUID3559

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4990NIGHTTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WALGREENS]7Current NDC, 1 package rows20241009_4657c02b-887b-4746-8a78-83a72465e07b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN4657c02b-887b-4746-8a78-83a72465e07b9
1234386dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD4657c02b-887b-4746-8a78-83a72465e07b9
1234386dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY4657c02b-887b-4746-8a78-83a72465e07b9
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY4657c02b-887b-4746-8a78-83a72465e07b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-4990-1200363499012355 mL in 1 BOTTLE, PLASTIC (0363-4990-12) 355 ml2024-03-01NoNoHistorical