Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Product NDC: 68999-302
Requested package NDC: 68999-302-24
11-digit product format: 689990302
Labeler code: 68999
Product ID: 68999-302_4472f94a-77ad-02c3-e063-6294a90a9cf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Chartwell Governmental & Specialty RX, LLC
Application: ANDA213125
Marketing category: ANDA
Marketing start: 2020-04-17
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 2; 10; 30 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: 2026-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2020-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213125-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213125-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2020-04-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213125-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213125-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213125-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213125-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213125-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213125-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213125-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213125-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213125-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213125-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213125-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213125-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213125-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213125-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213125-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213125-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213125-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213125-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213125-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213125-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213125-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213125-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213125-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213125-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213125-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213125-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213125-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213125-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213125-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213125-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213125-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213125-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213125-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213125-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213125-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213125-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213125-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	10 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	30 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
a19b75d4-67de-4904-8487-1f9b3368c833	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68999-302-05	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	5 mL in 1 CUP	SYRUP	5	1
68999-302-24	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	10 in 1 TRAY	SYRUP	10	1
68999-302-24	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	2 in 1 BOX	SYRUP	2	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Chartwell Governmental & Specialty RX, LLC	a19b75d4-67de-4904-8487-1f9b3368c833	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213125 application number: ANDA213125 ndc (package): 68999-302-24 ndc (product): 68999-302 ndc11 (package): 68999030224
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Chartwell RX, LLC	30f0317c-4793-4b88-8c06-c0f3cb12b3ea	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213125 application number: ANDA213125

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	a19b75d4-67de-4904-8487-1f9b3368c833	1
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	a19b75d4-67de-4904-8487-1f9b3368c833	1
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	a19b75d4-67de-4904-8487-1f9b3368c833	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68999-302-24	68999030224	2 TRAY in 1 BOX (68999-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-302-05)	2 tray	2025-10-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup 2 mg, 30 mg, 10 mg/ 5 mL Rx only	Chartwell Governmental & Specialty RX, LLC	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	1