Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Product NDC: 85766-250
11-digit product format: 857660250
Labeler code: 85766
Product ID: 85766-250_575430f0-08c6-a7eb-e063-6394a90ac220
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA203375
Marketing category: ANDA
Marketing start: 2025-02-01
Substance: BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 2; 30; 10 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2016-09-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203375-001	AA

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203375-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203375-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203375-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203375-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203375-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203375-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203375-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203375-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203375-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203375-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203375-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203375-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203375-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203375-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203375-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203375-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203375-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203375-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203375-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203375-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203375-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203375-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203375-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203375-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203375-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203375-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203375-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203375-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203375-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203375-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203375-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203375-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203375-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203375-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203375-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203375-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203375-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203375-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203375-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203375-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1357010	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f3afca82-ba8f-4741-8332-b7939aa0ee5e	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Sportpharm LLC	f3afca82-ba8f-4741-8332-b7939aa0ee5e	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203375 application number: ANDA203375 ndc (product): 85766-250
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Acella Pharmaceuticals, LLC	1045e307-f60d-482d-8e06-40e72b84c651	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203375 application number: ANDA203375
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Acella Pharmaceuticals, LLC	0c403f27-0b9b-4da3-a66b-1040eff1b2bf	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203375 application number: ANDA203375
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Proficient Rx LP	1b79a7d8-a8f4-4525-8b94-3e317fc5a717	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203375 application number: ANDA203375

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-250-04	85766025004	118 mL in 1 BOTTLE, PLASTIC (85766-250-04)	118 ml	2026-07-24	No	No	Current
85766-250-16	85766025016	473 mL in 1 BOTTLE, PLASTIC (85766-250-16)	473 ml	2026-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Syrup	Sportpharm LLC	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	1