FDA.reportPublic FDA data

DG Health Cold and Flu Relief

Product NDC
55910-737
11-digit product format
559100737
Labeler code
55910
Product ID
55910-737_082e5739-82d1-4699-9e7b-5085ca2dc50b
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-20
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
DG Health Cold and Flu Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN200 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-737-34DG Health Cold and Flu Relief237 mL in 1 BOTTLESOLUTION2376

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
GUAIFENESINACTIVE MOIETY495W7451VQDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-737DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP, LLC]6Current NDC, Legacy NDC, 1 package rows20241101_f01af1e0-7903-4ffb-92a2-02a78a3e29b8.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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
application number: M012
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
application number: M012
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd9f26677-ddef-4098-b564-9aa5734e088b2025-10-09WarningsExact identifier
application number: M012
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
application number: M012
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc020942b1-59d4-a19d-e063-6394a90a5d872025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 200ctMENTHOLDollar General Corporationa17aece2-abd8-452a-9da8-2e303845900b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporation51ccf39a-ae9b-4e6a-856c-002c296f5d072025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporationf85f1a15-db7f-4bb5-9313-24702660054e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporationd5fb7d9e-b0f6-4424-bf67-9e72b50366b12025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporationa23ec89a-de7e-4013-b85b-1593e18dc28e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation1833d3bf-6f01-4122-9f4d-4d8b2423fcbb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf01af1e0-7903-4ffb-92a2-02a78a3e29b86
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf01af1e0-7903-4ffb-92a2-02a78a3e29b86
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf01af1e0-7903-4ffb-92a2-02a78a3e29b86
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf01af1e0-7903-4ffb-92a2-02a78a3e29b86
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYf01af1e0-7903-4ffb-92a2-02a78a3e29b86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-737-3455910073734237 mL in 1 BOTTLE (55910-737-34) 237 ml2014-05-200000-00-00NoNoCurrent