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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
application number: M012
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
application number: M012
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
application number: M012
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
application number: M012
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
application number: M012
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
application number: M012
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC8dd039b4-209a-484a-b15e-741d55087a932026-08-18WarningsExact identifier
application number: M012
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
application number: M012
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
application number: M012
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
application number: M012
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsExact identifier
application number: M012
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsExact identifier
application number: M012
CVS HealthNASAL OXYMETAZOLINE HCLCVS Pharmacy,Inc.56f08e70-bf16-4933-97bc-177bc190d12a2026-08-17WarningsExact identifier
application number: M012
CVS Health No DripALLERGY NASALCVS PHARMACY,INC.3e76ffac-07a7-4b6a-bc4c-9cabb653e0642026-08-17WarningsExact identifier
application number: M012
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact identifier
application number: M012
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
application number: M012
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact 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