FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Product NDC
69729-036
11-digit product format
697290036
Labeler code
69729
Product ID
69729-036_5d208b0e-4c1e-33a3-e063-6394a90a806d
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
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
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-036-04DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-036DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC]6Current NDC, Legacy NDC, 1 package rows20250516_8bb85b23-e9f6-48c7-84b0-15e0e26df4c5.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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion ReliefGUAIFENESINTOPCO ASSOCIATES LLCb8339617-17ce-4ad7-af38-399ecc74d8642024-12-18WarningsExact identifier
application number: M012
Kroger Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETHE KROGER CO976bfdcf-2110-486c-aa6e-cd2067334cdc2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINAmerisourceBergen Drug Corp79cefd46-bd19-4a1d-9cb1-e85ff0f124942024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCardinal Health8397e1b9-e83e-4c6a-b858-1663c23658402024-12-18WarningsExact identifier
application number: M012
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
application number: M012
Meijer Chest Congestion ReliefGUAIFENESINMeijer Distribution Inc.ae02e0bd-d9e7-495f-b01f-b135b96934a02024-12-18WarningsExact identifier
application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PEGUAIFENESIN/PHENYLEPHRINETOPCO ASSOCIATES LLCb6c0362f-86ca-4f08-ba53-800c6df2c0252024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC10cad9a7-1223-470c-9027-807891217d402024-12-18WarningsExact identifier
application number: M012
Kroger Mucus ReliefGUAIFENESINTHE KROGER CO2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e2024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Association41f88b43-3e0a-4650-b167-a72afe6177e82024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
application number: M012
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012
Dollar General Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINDolgencorp, LLC718f08d2-3757-4f3e-915e-3e4982ad090f2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmerisourceBergen Drug Corpe4610d53-4459-43a0-9351-f0ac8586df602024-12-18WarningsExact identifier
application number: M012
Always Save Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEValu Merch5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f62024-12-17WarningsExact identifier
application number: M012
ChestrubCAMPHOR MENTHOL EUCALYPTUS OILDelta Brands Inc8e6f731f-c16a-41b2-9786-0cab588cfc8e2024-12-17WarningsExact identifier
application number: M012
Mentholatum Nighttime Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company5539ae74-9723-480d-b35f-0a6644bf54ad2024-12-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8bb85b23-e9f6-48c7-84b0-15e0e26df4c56
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8bb85b23-e9f6-48c7-84b0-15e0e26df4c56
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8bb85b23-e9f6-48c7-84b0-15e0e26df4c56
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY8bb85b23-e9f6-48c7-84b0-15e0e26df4c56
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY8bb85b23-e9f6-48c7-84b0-15e0e26df4c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-036-0469729003604118 mL in 1 BOTTLE (69729-036-04) 118 ml2021-02-010000-00-00NoNoCurrent