FDA.reportPublic FDA data

Night Time Cough

Product NDC
21130-499
11-digit product format
211300499
Labeler code
21130
Product ID
21130-499_fe3d9fc3-fb69-4c27-9c5f-e356968d046f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Night Time Cough
Listing expiration
2026-12-31

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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-499-12Night Time Cough355 mL in 1 BOTTLE, PLASTICLIQUID3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-499NIGHT TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.]4Current NDC, Legacy NDC, 1 package rows20240516_f658a03b-6fc2-4b63-b3ab-7e886fbf20b4.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 SolutionPSNf658a03b-6fc2-4b63-b3ab-7e886fbf20b44
1234386dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf658a03b-6fc2-4b63-b3ab-7e886fbf20b44
1234386dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf658a03b-6fc2-4b63-b3ab-7e886fbf20b44
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf658a03b-6fc2-4b63-b3ab-7e886fbf20b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-499-1221130049912355 mL in 1 BOTTLE, PLASTIC (21130-499-12) 355 ml2018-01-310000-00-00NoNoCurrent