Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Product NDC
42858-320
11-digit product format
428580320
Labeler code
42858
Product ID
42858-320_e5ff67d3-df79-4fb3-99e9-0e86068756f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA202955
Marketing category
ANDA
Marketing start
2022-10-12
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct42858-320DDiscontinued by firm2026-08-10
excluded packagepackage42858-32042858-320-12DDiscontinued by firm2026-08-10
excluded packagepackage42858-32042858-320-16DDiscontinued by firm2026-08-10

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 1 · 36 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 packagepackage42858-320-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42858-320-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42858-320-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42858-320-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42858-320-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42858-320-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42858-320-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42858-320-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42858-320-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42858-320-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42858-320-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42858-320-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42858-320-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42858-320-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42858-320-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42858-320-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42858-320-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42858-320-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42858-320-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42858-320-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42858-320-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42858-320-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42858-320-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42858-320-12557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-054b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORALAA2020-11-058869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202955-001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE2MG/5ML;10MG/5ML;30MG/5MLSYRUP / ORAL2020-11-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202955-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202955-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202955-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A202955-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202955-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202955-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A202955-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202955-001AA18869cabd3fbd…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-320-1242858032012118 mL in 1 BOTTLE, PLASTIC (42858-320-12) 118 ml2022-10-120000-00-00NoNoCurrent
42858-320-1642858032016473 mL in 1 BOTTLE, PLASTIC (42858-320-16) 473 ml2022-10-120000-00-00NoNoCurrent