Cough Relief

Product NDC
63941-309
11-digit product format
639410309
Labeler code
63941
Product ID
63941-309_a43cd6cb-7910-411f-889e-d14b463008fd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Marketing end
2027-03-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/5mL
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
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090496Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f49f1e9a-07ac-443e-9df8-3281d5f35e78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-309-04Cough Relief118 mL in 1 BOTTLE, PLASTICLIQUID1186
63941-309-04Cough Relief1 in 1 BOXLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)INACTIVE INGREDIENTL605B5892VCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-309COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]5Current NDC, Legacy NDC, 2 package rows20240215_f49f1e9a-07ac-443e-9df8-3281d5f35e78.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
application number: M012
CVS Health No DripNASAL MISTCVS PHARMACY,INC.60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa2026-08-17WarningsExact identifier
application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion ChildrensBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreens2bdc62b6-f3e1-4a79-9b29-00cc1d4280b32026-08-17WarningsExact identifier
application number: M012
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
application number: M012
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
application number: M012
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNf49f1e9a-07ac-443e-9df8-3281d5f35e786
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCDf49f1e9a-07ac-443e-9df8-3281d5f35e786
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSYf49f1e9a-07ac-443e-9df8-3281d5f35e786
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSYf49f1e9a-07ac-443e-9df8-3281d5f35e786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-309-04639410309041 BOTTLE, PLASTIC in 1 BOX (63941-309-04) / 118 mL in 1 BOTTLE, PLASTIC2015-06-302027-03-28NoNoCurrent