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 118 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
application number: M012
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
application number: M012
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
application number: M012
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
application number: M012
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
application number: M012
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
application number: M012
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
application number: M012
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efc46c9-a421-1998-e063-6394a90aeb642025-02-25WarningsExact identifier
application number: M012
Redicare Cough Drops Cherry FlavoredCHERRY FLAVORED MENTHOL COUGH DROPSRedicare LLC2efeaafa-ee96-37ee-e063-6394a90a9a4b2025-02-25WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC77a2dc96-73ee-4ca2-b1fe-4069958026062025-02-19WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact 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