FDA.reportPublic FDA data

Cough Relief

Product NDC
55910-309
11-digit product format
559100309
Labeler code
55910
Product ID
55910-309_de92fd31-93b0-48c8-8993-8a27da244f6f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-31
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
Listing certified through
2027-12-31
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
Brand name suffix
Adult
Listing expiration
2027-12-31

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
f5c57b32-69cb-469e-ad2d-64c00b5e66dcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-309-04Cough ReliefAdult118 mL in 1 BOTTLE, PLASTICLIQUID1185
55910-309-04Cough ReliefAdult1 in 1 BOXLIQUID15

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-309COUGH RELIEF ADULT (DEXTROMETHORPHAN HBR) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]5Current NDC, Legacy NDC, 2 package rows20241016_f5c57b32-69cb-469e-ad2d-64c00b5e66dc.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 103 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact identifier
application number: M012
AXIV NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC131f6314-c9a1-7af3-e063-6294a90abe6f2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLL.N.K. International, Inc.f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc52025-09-15WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNf5c57b32-69cb-469e-ad2d-64c00b5e66dc5
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCDf5c57b32-69cb-469e-ad2d-64c00b5e66dc5
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSYf5c57b32-69cb-469e-ad2d-64c00b5e66dc5
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSYf5c57b32-69cb-469e-ad2d-64c00b5e66dc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-309-04559100309041 BOTTLE, PLASTIC in 1 BOX (55910-309-04) / 118 mL in 1 BOTTLE, PLASTIC2015-08-310000-00-00NoNoCurrent