DG Health Cold and Flu Relief

Product NDC
55910-656
11-digit product format
559100656
Labeler code
55910
Product ID
55910-656_5655bf6e-38b6-480e-a6f9-f2e4254cb1a9
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-09-27
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-65655910-656-38DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-656-34DG Health Cold and Flu Relief237 mL in 1 BOTTLESOLUTION23710
55910-656-38DG Health Cold and Flu Relief296 mL in 1 BOTTLESOLUTION29610
55910-656-40DG Health Cold and Flu Relief355 mL in 1 BOTTLESOLUTION35510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
SUCROSEINACTIVE INGREDIENTC151H8M554DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-656DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [DOLGENCORP INC]10Current NDC, Legacy NDC, 3 package rows20240927_f27bca25-da5f-4a28-adff-75e1d326facc.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 167 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact identifier
application number: M012
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5f2b16f0-c58b-4e48-ad92-eaab93c6c4b22024-03-12WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger FlavorACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC18dcede2-5a38-40fa-93fe-48acdd6a7cf12024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry FlavorACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCd4ce06aa-776f-45e4-a1a6-9cf13797048f2024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC14e38ef0-a5e7-4df7-824f-f27bef664d252024-03-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC68d3e88a-d1be-410b-92a1-863903b3aa612024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
application number: M012
Theraflu PowerPods Daytime Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCe655c33c-c319-41d9-ae55-cf747242cd102024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCadf33520-4689-4de2-b9d8-c201518e9d262024-03-08WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCf6ae9e3a-6bea-40e0-8a6f-45f4be8319e72024-03-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf27bca25-da5f-4a28-adff-75e1d326facc10
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf27bca25-da5f-4a28-adff-75e1d326facc10
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf27bca25-da5f-4a28-adff-75e1d326facc10
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf27bca25-da5f-4a28-adff-75e1d326facc10
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYf27bca25-da5f-4a28-adff-75e1d326facc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-656-3455910065634237 mL in 1 BOTTLE (55910-656-34) 237 ml2015-05-060000-00-00NoNoCurrent
55910-656-3855910065638296 mL in 1 BOTTLE (55910-656-38) 296 ml2009-09-270000-00-00NoNoCurrent
55910-656-4055910065640355 mL in 1 BOTTLE (55910-656-40) 355 ml2015-05-070000-00-00NoNoCurrent