Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC: 0574-1104
Requested package NDC: 0574-1104-04
11-digit product format: 005741104
Labeler code: 0574
Product ID: 0574-1104_aa6625e1-c78d-417a-bdf3-fc09a5b26966
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Padagis US LLC
Application: ANDA205292
Marketing category: ANDA
Marketing start: 2015-02-06
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
A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205292-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	2014-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205292-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205292-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205292-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205292-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205292-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205292-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205292-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205292-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205292-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205292-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205292-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205292-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205292-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205292-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205292-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205292-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205292-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205292-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205292-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205292-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205292-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205292-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205292-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205292-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205292-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205292-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205292-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205292-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205292-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205292-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205292-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205292-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205292-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205292-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205292-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205292-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205292-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205292-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205292-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205292-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205292-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
06db369d-09fe-4ca2-b98c-705356b7c403	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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	Strength	SPL version
0574-1104-04	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118		6
0574-1104-16	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	473 mL in 1 BOTTLE, PLASTIC	SYRUP	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-1104-04	ML - Milliliter	0574-1104	2be4169a-7708-46e0-a135-18cd96ec76c3	1	2015-03-03
0574-1104-16	ML - Milliliter	0574-1104	efa07042-0a77-4257-84d5-c6aef68af2f7	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-1104	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADAGIS US LLC]	5	Current NDC, Legacy NDC, 2 package rows	20230329_06db369d-09fe-4ca2-b98c-705356b7c403.zip

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 · 7 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	REMEDYREPACK INC.	35236e4a-6e98-4c4d-85bf-7551fd08d700	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	85b98fa3-376c-41a3-b3c1-0c739d903a22	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Padagis US LLC	06db369d-09fe-4ca2-b98c-705356b7c403	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292 ndc (package): 0574-1104-04 ndc (product): 0574-1104 ndc11 (package): 00574110404
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	4368822d-2779-4fb2-9ca9-f020b8934dc5	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	51c95c28-8979-4b75-b1d6-856875106587	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	440d0554-995c-47df-b9f6-f3e3ce2e35e0	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Proficient Rx LP	ed9399e2-2be8-4793-99c5-204779c2a471	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205292 application number: ANDA205292

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	85b98fa3-376c-41a3-b3c1-0c739d903a22	104
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	4368822d-2779-4fb2-9ca9-f020b8934dc5	104
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	85b98fa3-376c-41a3-b3c1-0c739d903a22	104
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	4368822d-2779-4fb2-9ca9-f020b8934dc5	104
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	85b98fa3-376c-41a3-b3c1-0c739d903a22	104
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	4368822d-2779-4fb2-9ca9-f020b8934dc5	104
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	51c95c28-8979-4b75-b1d6-856875106587	102
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	51c95c28-8979-4b75-b1d6-856875106587	102
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	51c95c28-8979-4b75-b1d6-856875106587	102
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	06db369d-09fe-4ca2-b98c-705356b7c403	6
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	06db369d-09fe-4ca2-b98c-705356b7c403	6
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	06db369d-09fe-4ca2-b98c-705356b7c403	6
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	440d0554-995c-47df-b9f6-f3e3ce2e35e0	5
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	440d0554-995c-47df-b9f6-f3e3ce2e35e0	5
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	440d0554-995c-47df-b9f6-f3e3ce2e35e0	5
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	35236e4a-6e98-4c4d-85bf-7551fd08d700	4
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	35236e4a-6e98-4c4d-85bf-7551fd08d700	4
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	35236e4a-6e98-4c4d-85bf-7551fd08d700	4
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	ed9399e2-2be8-4793-99c5-204779c2a471	3
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	ed9399e2-2be8-4793-99c5-204779c2a471	3
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	ed9399e2-2be8-4793-99c5-204779c2a471	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-1104-04	00574110404	118 mL in 1 BOTTLE, PLASTIC (0574-1104-04)	118 ml	2015-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Bryant Ranch Prepack	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	104
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup	Padagis US LLC	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	7
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Bryant Ranch Prepack	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	104
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Preferred Pharmaceuticals Inc.	2024-03-11	HUMAN PRESCRIPTION DRUG LABEL	2
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Bryant Ranch Prepack	2023-08-16	HUMAN PRESCRIPTION DRUG LABEL	102
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	A-S Medication Solutions	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	5
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup	Preferred Pharmaceuticals Inc.	2019-06-20	HUMAN PRESCRIPTION DRUG LABEL	4