FDA.reportPublic FDA data

BRONCOCHEM

Product NDC
65131-091
11-digit product format
651310091
Labeler code
65131
Product ID
65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBr-GYAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-12-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 200 mg/10mL; mg/10mL
Pharmacologic classes
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/10mL
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1234473

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-091-08BRONCOCHEMMAXIMUM COUGH120 mL in 1 BOTTLE, PLASTICSYRUP1203
65131-091-08BRONCOCHEMMAXIMUM COUGH1 in 1 BOXSYRUP13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-091BRONCOCHEM MAXIMUM COUGH (DEXTROMETHORPHAN HBR-GYAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]3Current NDC, Legacy NDC, 2 package rows20161230_8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234473dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8aa32b2a-a8be-4f8d-9b1f-eb007bff8e653
1234473dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8aa32b2a-a8be-4f8d-9b1f-eb007bff8e653
1234473dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8aa32b2a-a8be-4f8d-9b1f-eb007bff8e653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65131-091-08651310091081 BOTTLE, PLASTIC in 1 BOX (65131-091-08) / 120 mL in 1 BOTTLE, PLASTIC2016-12-300000-00-00NoNoCurrent