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 102 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact 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