FDA.reportPublic FDA data

Cough Relief

Product NDC
63941-499
11-digit product format
639410499
Labeler code
63941
Product ID
63941-499_50360a87-8e50-42a9-838c-c94b95c84fdb
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
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
Cough Relief
Brand name suffix
Nighttime
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
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
63941-499-08Cough ReliefNighttime237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-499COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]6Current NDC, Legacy NDC, 1 package rows20240906_344282fc-3bd1-4f49-9bd1-08c5a58d1f73.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 SolutionPSN344282fc-3bd1-4f49-9bd1-08c5a58d1f736
1234386dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD344282fc-3bd1-4f49-9bd1-08c5a58d1f736
1234386dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY344282fc-3bd1-4f49-9bd1-08c5a58d1f736
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY344282fc-3bd1-4f49-9bd1-08c5a58d1f736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-499-0863941049908237 mL in 1 BOTTLE, PLASTIC (63941-499-08) 237 ml2018-01-310000-00-00NoNoCurrent