FDA.reportPublic FDA data

dg health flu and severe cold and cough

Product NDC
55910-964
11-digit product format
559100964
Labeler code
55910
Product ID
55910-964_5b74b9de-27c2-2724-e063-6394a90a7a78
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Dolgencorp, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-24
Marketing end
2027-02-28
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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 flu and severe cold and cough

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-964-912024-01-30C16284748780-11030e365-1d41-111a-e063-dadaa90a10e2Dolgencorp, LLC Flu & Severe Cold & Cough Drug Facts
55910-964-912024-01-30C16284748780-11030e365-1d41-111a-e063-dadaa90a10e2Dolgencorp, LLC Flu & Severe Cold & Cough Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-964-91dg health flu and severe cold and cough6 in 1 CARTONPOWDER, FOR SOLUTION610

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
SUCROSEINACTIVE INGREDIENTC151H8M554DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-964DG HEALTH FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [DOLGENCORP, LLC]10Current NDC, Legacy NDC, 1 package rows20240718_6118e90b-8a3a-4260-8a5a-4ed11e724dcc.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 104 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact identifier
application number: M012
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
application number: M012
Physicians Care Cough and Sore ThroatMENTHOLAcme United Corporation4e02223d-f34b-333e-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M012
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Sinus Non-DrowsyPHENYLEPHRINE HCLAcme United Corporationa6daf3ef-f386-4de4-b38e-d0b90c9ae62b2025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
application number: M012
Green Guard Honey Lemon Cough DropMENTHOL 8.6 MGUnifirst First Aid Corporation8a94f090-61d6-4909-e053-2995a90aee382025-09-08WarningsExact identifier
application number: M012
Green Guard Cough Drop ReliefMENTHOLUnifirst First Aid Corporation0fc4cb11-8ff9-4eff-9588-c73eef4e01372025-09-08WarningsExact identifier
application number: M012
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
application number: M012
MEDIQUE Medikoff DropsMENTHOLUnifirst First Aid Corporation0d6b4443-16a1-4851-bb03-d7407167551d2025-09-08WarningsExact identifier
application number: M012
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
application number: M012
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
application number: M012
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN6118e90b-8a3a-4260-8a5a-4ed11e724dcc10
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD6118e90b-8a3a-4260-8a5a-4ed11e724dcc10
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY6118e90b-8a3a-4260-8a5a-4ed11e724dcc10
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY6118e90b-8a3a-4260-8a5a-4ed11e724dcc10
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY6118e90b-8a3a-4260-8a5a-4ed11e724dcc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-964-91559100964916 POWDER, FOR SOLUTION in 1 CARTON (55910-964-91) 2011-05-242027-02-28NoNoCurrent