FDA.reportPublic FDA data

up and up cough plus chest congestion

Product NDC
11673-627
11-digit product format
116730627
Labeler code
11673
Product ID
11673-627_97a96c55-b62c-4537-9fb5-e27fccea026e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Target Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
Pharmacologic classes
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]
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 packagepackage11673-62711673-627-26DDiscontinued by firm2026-10-27

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 cough plus chest congestion
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-627-26up and up cough plus chest congestion1 in 1 CARTONSOLUTION14
11673-627-26up and up cough plus chest congestion118 mL in 1 BOTTLESOLUTION1184
11673-627-34up and up cough plus chest congestion236 mL in 1 BOTTLESOLUTION2364
11673-627-34up and up cough plus chest congestion1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-627UP AND UP COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TARGET CORPORATION]4Current NDC, Legacy NDC, 4 package rows20241114_ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c.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 176 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
application number: M012
Maximum strength Day cold and flu and Night severe cold and fluACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETSTIME CAP LABORATORIES,INCfff69901-965c-5372-e053-6394a90a29c22023-09-18WarningsExact identifier
application number: M012
Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAARNA USA, Inc.6e488782-0138-436d-a9f0-0ec5bc9daedd2023-05-15WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2023-01-17WarningsExact identifier
application number: M012
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992023-01-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH-E-Bdb19b8c7-0334-0664-e053-2a95a90ad61f2023-01-14WarningsExact identifier
application number: M012
NightimeACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEH-E-Bdb44560b-da02-74c9-e053-2a95a90af0b62023-01-13WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCLWalgreensdbf5656b-9105-871b-e053-2995a90a49412023-01-03WarningsExact identifier
application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa2508699-08c0-4a22-e053-2a95a90a8a6d2022-11-02WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
application number: M012
Mucus Relief DMMUCUS RELIEF DMTopCo Associates, LLC71674a9b-89ed-43d1-aadb-b9311fdfbdf92022-06-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Combo PackDAYTIME NIGHTTIME COLD AND FLUAllegiant Healthfa7ed5db-4da7-46b4-a08d-1d79cb7a56742022-05-19WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMGood Sense26a199bf-57e5-4f36-b40c-83a1187e48702022-05-18WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEGood Sensef88e2654-8e97-4cf6-9c36-01aeb51a91022021-11-30WarningsExact identifier
application number: M012
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
application number: M012
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-627-26116730627261 BOTTLE in 1 CARTON (11673-627-26) > 118 mL in 1 BOTTLE1 bottle2022-10-140000-00-00NoNoCurrent
11673-627-34116730627341 BOTTLE in 1 CARTON (11673-627-34) / 236 mL in 1 BOTTLE1 bottle2018-08-230000-00-00NoNoCurrent