Bronkids

Product NDC
49963-210
11-digit product format
499630210
Labeler code
49963
Product ID
49963-210_a2c5b8a8-e7ca-4e6c-9432-538ca8294077
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine/Dextromethorphan/Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
Portal Pharmaceutical
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-08-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49963-210IInactivated by FDA2026-10-05
excluded packagepackage49963-21049963-210-01IInactivated by FDA2026-10-05
excluded packagepackage49963-21049963-210-04IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49963-210-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49963-210-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49963-210-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49963-210-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49963-210-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49963-210-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49963-210-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49963-210-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49963-210-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49963-210-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49963-210-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49963-210-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49963-210-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49963-210-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49963-210-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49963-210-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49963-210-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49963-210-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49963-210-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49963-210-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49963-210-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49963-210-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49963-210-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49963-210-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49963-210-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49963-210-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49963-210-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49963-210-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49963-210-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49963-210-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49963-210-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49963-210-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49963-210-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49963-210-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49963-210-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49963-210-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49963-210-018dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49963-210-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49963-210-01e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49963-210-04e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
49963-210-012019-10-21C16284748780-1956f9ecf-c05a-621f-e053-dbdaa90a74adDrug Facts
49963-210-042019-10-21C16284748780-1956f9ecf-c05a-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-210-01Bronkids30 mL in 1 BOTTLE, PLASTICLIQUID301
49963-210-04Bronkids118 mL in 1 BOTTLE, PLASTICLIQUID1181

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
SORBITOLINACTIVE INGREDIENT506T60A25RBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1
WATERINACTIVE INGREDIENT059QF0KO0RBRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-210BRONKIDS (CHLORPHENIRAMINE/DEXTROMETHORPHAN/PHENYLEPHRINE) LIQUID [PORTAL PHARMACEUTICAL]1Legacy NDC, 2 package rows20100505_5488d81a-5a49-44f9-b16b-1cb55c35b175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086443chlorpheniramine maleate 4 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN5488d81a-5a49-44f9-b16b-1cb55c35b1751
1086443chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD5488d81a-5a49-44f9-b16b-1cb55c35b1751
1086443chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY5488d81a-5a49-44f9-b16b-1cb55c35b1751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49963-210-014996302100130 mL in 1 BOTTLE, PLASTIC30 mlHistorical
49963-210-0449963021004118 mL in 1 BOTTLE, PLASTIC118 mlHistorical