Bromfed DM

Product NDC: 68025-002
Requested package NDC: 68025-002-16
11-digit product format: 680250002
Labeler code: 68025
Product ID: 68025-002_ed39203a-d496-c2f1-e053-2995a90a1f3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Vertical Pharmaceuticals, LLC
Application: ANDA203375
Marketing category: ANDA
Marketing start: 2022-12-31
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68025-002	68025-002-16	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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-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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203375-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2016-09-20	`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	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…`
2022-09-29 23:25 UTC	2022-09	A203375-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203375-001	AA	1	`cb3db0bc1861…`

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
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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68025-002-16	68025000216	473 mL in 1 BOTTLE, PLASTIC (68025-002-16)	473 ml	2022-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bromfed™ DM Vertical Pharmaceuticals, LLC Rx only	Vertical Pharmaceuticals, LLC	2022-11-11	HUMAN PRESCRIPTION DRUG LABEL	1