Broncomar

Product NDC
53113-217
11-digit product format
531130217
Labeler code
53113
Product ID
53113-217_19ec0ebe-5667-42f4-b790-076aa1d008b7
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Gadal Laboratories Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53113-217-062019-11-27C16284748780-19855e2a2-3c42-60a7-e053-dbdaa90a05bde0ce818c-ef25-4889-adb2-94461f101b2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-217-06BroncomarDM1 in 1 CARTONLIQUID11
53113-217-06BroncomarDM177 mL in 1 BOTTLELIQUID1771

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
EUCALYPTUS CAMALDULENSIS LEAF OILINACTIVE INGREDIENTSN6D1J15I6BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GINKGO BILOBA WHOLEINACTIVE INGREDIENT660486U6OIBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
HONEYINACTIVE INGREDIENTY9H1V576FHBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
HOREHOUNDINACTIVE INGREDIENTK08036XEJVBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
LICORICEINACTIVE INGREDIENT61ZBX54883BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ABRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MULLEIN LEAFINACTIVE INGREDIENT9936O846LIBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MYRRHINACTIVE INGREDIENTJC71GJ1F3LBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HABRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBBRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53113-217BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1Legacy NDC, 2 package rows20140613_e0ce818c-ef25-4889-adb2-94461f101b2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNe0ce818c-ef25-4889-adb2-94461f101b2a1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe0ce818c-ef25-4889-adb2-94461f101b2a1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe0ce818c-ef25-4889-adb2-94461f101b2a1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYe0ce818c-ef25-4889-adb2-94461f101b2a1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYe0ce818c-ef25-4889-adb2-94461f101b2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53113-217-06531130217061 in 1 CARTONHistorical