FDA.reportPublic FDA data

Bronkids

Product NDC
49963-118
11-digit product format
499630118
Labeler code
49963
Product ID
49963-118_85b201f0-1f3b-4401-ad6d-b76c270ff883
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Portal Pharmaceutical
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-04-03
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1 mg/mL; mg/mL; mg/mL
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
49963-118-012019-11-27C16284748780-19855d018-d493-cd31-e053-dbdaa90ab51aBronkids Oral Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-118-01Bronkids1 in 1 CARTONLIQUID12
49963-118-01Bronkids30 mL in 1 BOTTLELIQUID302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49963-118-01ML - Milliliter49963-1185595e9b6-a180-4015-8240-f59859e2694112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9ZBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
ChlorpheniramineACTIVE MOIETY3U6IO1965UBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
DextromethorphanACTIVE MOIETY7355X3ROTSBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
PhenylephrineACTIVE MOIETY1WS297W6MVBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
SorbitolINACTIVE INGREDIENT506T60A25RBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2
WaterINACTIVE INGREDIENT059QF0KO0RBRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-118BRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]2Legacy NDC, 2 package rows20130104_12e5b41b-6a30-456c-9242-45fe7e9e45d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
700949chlorpheniramine maleate 0.6 MG / dextromethorphan HBr 2.75 MG / phenylephrine HCl 1.5 MG in 1 mL Oral SolutionPSN12e5b41b-6a30-456c-9242-45fe7e9e45d82
700949chlorpheniramine maleate 0.6 MG/ML / dextromethorphan hydrobromide 2.75 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD12e5b41b-6a30-456c-9242-45fe7e9e45d82
700949chlorpheniramine maleate 0.6 MG / dextromethorphan HBr 2.75 MG / phenylephrine HCl 1.5 MG per 1 ML Oral SolutionSY12e5b41b-6a30-456c-9242-45fe7e9e45d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49963-118-01499630118011 in 1 CARTONHistorical