FDA.reportPublic FDA data

Up and Up maximum Strength fast mucus relief

Product NDC
11673-738
11-digit product format
116730738
Labeler code
11673
Product ID
11673-738_42d69f51-b195-468f-e063-6394a90ae0e2
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Target Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 mg/20mL; mg/20mL; mg/20mL
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
2026-12-31
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
Up and Up maximum Strength fast mucus relief
Brand name suffix
Severe Congestion and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal 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
1043543Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f007beaa-b108-46d5-8a98-853f011a8e2eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-738-06Up and Up maximum Strength fast mucus reliefSevere Congestion and Cough177 mL in 1 BOTTLELIQUID1778

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-738UP AND UP MAXIMUM STRENGTH FAST MUCUS RELIEF SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TARGET CORPORATION]7Current NDC, Legacy NDC, 1 package rows20241109_f007beaa-b108-46d5-8a98-853f011a8e2e.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 95 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
application number: M012
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNf007beaa-b108-46d5-8a98-853f011a8e2e8
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDf007beaa-b108-46d5-8a98-853f011a8e2e8
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYf007beaa-b108-46d5-8a98-853f011a8e2e8
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYf007beaa-b108-46d5-8a98-853f011a8e2e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-738-0611673073806177 mL in 1 BOTTLE (11673-738-06) 177 ml2015-11-100000-00-00NoNoCurrent