G-BRONCO-D

Product NDC
43913-403
11-digit product format
439130403
Labeler code
43913
Product ID
43913-403_509fb31b-09bb-4671-be8f-3dcf1771cbd3
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
MCLAREN MEDICAL INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200 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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43913-403-162020-01-31C16284748780-19d75b9d0-79ed-f424-e053-dadaa90a57ceG-BRONCO-D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43913-403-16G-BRONCO-D474 mL in 1 BOTTLESUSPENSION4741

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
GUAIFENESINACTIVE MOIETY495W7451VQG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
HYDROXYMETHYL CELLULOSEINACTIVE INGREDIENT273FM27VK1G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RG-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43913-403G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]1Legacy NDC, 1 package rows20150919_632d4219-7c36-4ed1-a5d0-7d0021b778a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486140dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral SuspensionPSN632d4219-7c36-4ed1-a5d0-7d0021b778a91
1486140dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SuspensionSCD632d4219-7c36-4ed1-a5d0-7d0021b778a91
1486140dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral SuspensionSY632d4219-7c36-4ed1-a5d0-7d0021b778a91
1486140dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral SuspensionSY632d4219-7c36-4ed1-a5d0-7d0021b778a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43913-403-1643913040316474 mL in 1 BOTTLE474 mlHistorical