FDA.reportPublic FDA data

adult cough and chest congestion

Product NDC
79481-0063
11-digit product format
794810063
Labeler code
79481
Product ID
79481-0063_5481b2e8-f2e6-4e1b-991e-2904705a4760
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 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

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
adult cough and chest congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 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
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b11c4cee-bbb5-4585-9d38-6787553e13a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0063-0adult cough and chest congestion1 in 1 CARTONSOLUTION13
79481-0063-0adult cough and chest congestion237 mL in 1 BOTTLESOLUTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0063ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MEIJER, INC.]3Current NDC, Legacy NDC, 2 package rows20241003_b11c4cee-bbb5-4585-9d38-6787553e13a0.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 138 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerican Sales Company6c90fccf-0e6f-43df-9468-d8ece8ded0092024-11-11WarningsExact identifier
application number: M012
good sense night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company89dc1423-d097-47a8-9025-eab5381cca262024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC10f9627b-edda-422a-b01f-7066f9c983352024-11-11WarningsExact identifier
application number: M012
nighttime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED17c3fe42-3c40-4405-80b7-b3f9e4aa83762024-11-11WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B1dd36aa7-f085-4350-8cf2-f9fa29b583e42024-11-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7f9f1d0-7498-461c-b4e8-4c92cf3feae82024-11-11WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreen Companybd079f5d-0a38-40e6-9661-e8236c88a24d2024-11-11WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCe1118592-30ac-4505-9f38-c6d395c4cf5b2024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
application number: M012
Biofreeze ColorlessMENTHOLA-S Medication Solutionscc1cba14-da40-4d7d-b522-b5c648798e962024-11-11WarningsExact identifier
application number: M012
foster and thrive nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC298b7754-d0d8-496d-9949-4c346cb11e342024-11-11WarningsExact identifier
application number: M012
leader tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderb418c10c-528b-4395-944e-af959b639ec22024-11-10WarningsExact identifier
application number: M012
equaline adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFIf7c753f8-4b12-4797-a599-736d597bc1bc2024-11-10WarningsExact identifier
application number: M012
foster and thrive adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrategic Sourcing Services LLCf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72024-11-10WarningsExact identifier
application number: M012
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNb11c4cee-bbb5-4585-9d38-6787553e13a03
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDb11c4cee-bbb5-4585-9d38-6787553e13a03
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYb11c4cee-bbb5-4585-9d38-6787553e13a03
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYb11c4cee-bbb5-4585-9d38-6787553e13a03
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYb11c4cee-bbb5-4585-9d38-6787553e13a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0063-0794810063001 BOTTLE in 1 CARTON (79481-0063-0) / 237 mL in 1 BOTTLE1 bottle2022-06-100000-00-00NoNoCurrent