FDA.reportPublic FDA data

Brontuss

Product NDC
49963-913
11-digit product format
499630913
Labeler code
49963
Product ID
49963-913_5012801b-7bba-48d0-8636-68300642c6bd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Portal Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-11-24
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/5mL; 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
49963-913-042019-10-21C16284748780-1956f9ecf-da1f-621f-e053-dbdaa90a74adBrontuss DX
49963-913-152019-10-21C16284748780-1956f9ecf-da1f-621f-e053-dbdaa90a74adBrontuss DX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-913-04BrontussDX118 mL in 1 BOTTLELIQUID1182
49963-913-15BrontussDX15 mL in 1 BOTTLELIQUID152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49963-913-04ML - Milliliter49963-913c81fa09c-c0db-43de-b438-82317d38c56412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2
GuaifenesinACTIVE INGREDIENT495W7451VQBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2
DextromethorphanACTIVE MOIETY7355X3ROTSBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2
GuaifenesinACTIVE MOIETY495W7451VQBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2
PhenylephrineACTIVE MOIETY1WS297W6MVBRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-913BRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]2Legacy NDC, 2 package rows20091221_c83c41c1-e66f-4aea-82ad-2028dbf50f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039286dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSNc83c41c1-e66f-4aea-82ad-2028dbf50f952
1039286dextromethorphan hydrobromide 4 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCDc83c41c1-e66f-4aea-82ad-2028dbf50f952
1039286dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSYc83c41c1-e66f-4aea-82ad-2028dbf50f952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49963-913-0449963091304118 mL in 1 BOTTLE118 mlHistorical
49963-913-154996309131515 mL in 1 BOTTLE15 mlHistorical