BRONCOCHEM

Product NDC
65131-180
11-digit product format
651310180
Labeler code
65131
Product ID
65131-180_c63d515a-0755-4d0e-8aba-aca050df0456
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBr-GUAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/15mL; mg/15mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
BRONCOCHEM
Brand name suffix
MAXIMUM COUGH KIDS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN100 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298228

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
65131-180-98BRONCOCHEMMAXIMUM COUGH KIDS1 in 1 BOXSYRUP14
65131-180-98BRONCOCHEMMAXIMUM COUGH KIDS120 mL in 1 BOTTLE, PLASTICSYRUP1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-180BRONCOCHEM MAXIMUM COUGH KIDS (DEXTROMETHORPHAN HBR-GUAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]4Current NDC, Legacy NDC, 2 package rows20250316_b0fd2f2f-5cc4-4813-8f99-c78fbe898656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSNb0fd2f2f-5cc4-4813-8f99-c78fbe8986564
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCDb0fd2f2f-5cc4-4813-8f99-c78fbe8986564
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSYb0fd2f2f-5cc4-4813-8f99-c78fbe8986564
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSYb0fd2f2f-5cc4-4813-8f99-c78fbe8986564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65131-180-98651310180981 BOTTLE, PLASTIC in 1 BOX (65131-180-98) / 120 mL in 1 BOTTLE, PLASTIC2017-05-010000-00-00NoNoCurrent