FDA.reportPublic FDA data

BRONCOCHEM

Product NDC
65131-100
11-digit product format
651310100
Labeler code
65131
Product ID
65131-100_cc073936-6e23-479a-a8cc-63e844f4bfb0
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBr-GYAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/10mL; mg/10mL
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
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
BRONCOCHEM
Brand name suffix
MAXIMUM COUGH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN400 mg/10mL

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
1046631Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
deecdb72-4cdb-4d6f-972f-a425a91afa5aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-100-91BRONCOCHEMMAXIMUM COUGH120 mL in 1 BOTTLE, PLASTICSYRUP1201
65131-100-91BRONCOCHEMMAXIMUM COUGH1 in 1 BOXSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-100BRONCOCHEM MAXIMUM COUGH (DEXTROMETHORPHAN HBR-GYAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, 2 package rows20250421_deecdb72-4cdb-4d6f-972f-a425a91afa5a.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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Street Antibacterial Liquid HandBENZALKONIUM CHLORIDEAmerifoods Trading Companye9d5fefa-970b-42ba-8139-18e5644153442025-11-06WarningsExact identifier
application number: M
CetirzaCETIRIZINE HCLHART Health44b22f6f-5731-4dfe-af33-4e4e54fc3af52025-10-06WarningsExact identifier
application number: M
Dolce and Gabbana Blueberry Nutri Tint SPF 20 6W LightZINC OXIDEDolce & Gabbana Beauty S.R.Ld2930d0e-c622-4843-87f2-fa1a92837ff22025-09-05WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed959815e5-a73b-4905-9d7d-904b334983862025-08-15WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthc1903b9f-390a-4756-800c-fd93be4182e32025-08-13Warnings, Adverse reactionsExact identifier
application number: M
THERASTATCHERRY COUGH DROPSHART Health96bae19a-3337-4199-9b8c-cdf9b368178b2025-08-04WarningsExact identifier
application number: M
Docu LiquidDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.f4ed0721-3be9-4108-a6c9-dbbe115249e92025-07-31WarningsExact identifier
application number: M
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.ac6a47e7-972f-4b82-96da-89926d345e9f2025-07-31WarningsExact identifier
application number: M
SENNASENNAATLANTIC BIOLOGICALS CORP.8b7cc0d5-029b-43f7-a050-8771e7db45512025-07-31WarningsExact identifier
application number: M
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGATLANTIC BIOLOGICALS CORP.4c02fcec-6bb7-4497-96c5-0d809209dd172025-06-27WarningsExact identifier
application number: M
Orythia Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d658d495-dd2c-40b7-9446-6f10040ed55e2025-06-27WarningsExact identifier
application number: M
Bonica EaseX Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.34f1196a-fda1-4bef-be71-e5a09ee97bc12025-06-27WarningsExact identifier
application number: M
Regular Strength Enteric coated aspirinASPIRINATLANTIC BIOLOGICALS CORP.e1c8d0ed-da1d-4b1a-9a85-7b8532775f872025-06-24WarningsExact identifier
application number: M
Aspirin Low Dose Chewable OrangeASPIRINATLANTIC BIOLOGICALS CORP.a0d8ee59-1ce0-4ddd-a90c-54adb512540c2025-06-24WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Healthf50af223-ba83-458a-a557-1ba5dc221a9c2025-06-10WarningsExact identifier
application number: M
Pharbetol Regular strengthACETAMINOPHENATLANTIC BIOLOGICALS CORP.05a91d24-b498-4ba2-a275-68b871cf62d22025-06-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
application number: M
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
application number: M
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEATLANTIC BIOLOGICALS CORP.5c02d0ba-91e4-4bd2-ac66-6905323653b22025-05-12WarningsExact identifier
application number: M
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINATLANTIC BIOLOGICALS CORP.8f496c61-41a6-41ba-80f5-7a5309c4d18b2025-05-12WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046631dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 10 mL Oral SolutionPSNdeecdb72-4cdb-4d6f-972f-a425a91afa5a1
1046631dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCDdeecdb72-4cdb-4d6f-972f-a425a91afa5a1
1046631dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral SolutionSYdeecdb72-4cdb-4d6f-972f-a425a91afa5a1
1046631dextromethorphan HBr 20 MG / guaifenesin 400 MG per 10 ML Oral SolutionSYdeecdb72-4cdb-4d6f-972f-a425a91afa5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65131-100-91651310100911 BOTTLE, PLASTIC in 1 BOX (65131-100-91) / 120 mL in 1 BOTTLE, PLASTIC2025-04-21NoNoCurrent