Triacting Daytime Cold Cough

Product NDC
55910-378
11-digit product format
559100378
Labeler code
55910
Product ID
55910-378_63718d09-5af9-49c2-b2e2-00d868e059cd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 2.5 mg/5mL; mg/5mL
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

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
Triacting Daytime Cold Cough
Brand name suffix
Childrens
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1535366Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8656aa2e-9546-4de4-9ecc-ce99bf903333Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-378-04Triacting Daytime Cold CoughChildrens1 in 1 BOXSYRUP18
55910-378-04Triacting Daytime Cold CoughChildrens118 mL in 1 BOTTLE, PLASTICSYRUP1188

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
MALTITOLINACTIVE INGREDIENTD65DG142WKTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3
WATERINACTIVE INGREDIENT059QF0KO0RTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-378TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]8Current NDC, Legacy NDC, 2 package rows20231011_8656aa2e-9546-4de4-9ecc-ce99bf903333.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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact identifier
application number: M012
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535366dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SuspensionPSN8656aa2e-9546-4de4-9ecc-ce99bf9033338
1535366dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD8656aa2e-9546-4de4-9ecc-ce99bf9033338
1535366dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SuspensionSY8656aa2e-9546-4de4-9ecc-ce99bf9033338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-378-04559100378041 BOTTLE, PLASTIC in 1 BOX (55910-378-04) / 118 mL in 1 BOTTLE, PLASTIC2014-05-300000-00-00NoNoCurrent