FDA.reportPublic FDA data

Bronkids

Product NDC
49963-532
11-digit product format
499630532
Labeler code
49963
Product ID
49963-532_c386c458-4510-437b-beb7-5d5ec607a732
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Portal Pharmaceutical
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-10
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49963-532-012019-11-13C16284748780-197449f38-d502-f6ea-e053-dbdaa90aa703Bronkids Liquid
49963-532-042019-11-13C16284748780-197449f38-d502-f6ea-e053-dbdaa90aa703Bronkids Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-532-01Bronkids30 mL in 1 BOTTLELIQUID303
49963-532-04Bronkids118 mL in 1 BOTTLELIQUID1183

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9ZBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
ChlorpheniramineACTIVE MOIETY3U6IO1965UBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
DextromethorphanACTIVE MOIETY7355X3ROTSBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
PhenylephrineACTIVE MOIETY1WS297W6MVBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Citric AcidINACTIVE INGREDIENT2968PHW8QPBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
SorbitolINACTIVE INGREDIENT506T60A25RBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3
WaterINACTIVE INGREDIENT059QF0KO0RBRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-532BRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]3Legacy NDC, 2 package rows20111122_11943d27-da4d-44ec-b0e7-e468e18d2b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291266chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN11943d27-da4d-44ec-b0e7-e468e18d2b6c3
1291266chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD11943d27-da4d-44ec-b0e7-e468e18d2b6c3
1291266chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY11943d27-da4d-44ec-b0e7-e468e18d2b6c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49963-532-014996305320130 mL in 1 BOTTLE30 mlHistorical
49963-532-0449963053204118 mL in 1 BOTTLE118 mlHistorical