BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE

Product NDC: 64376-657
11-digit product format: 643760657
Labeler code: 64376
Product ID: 64376-657_8cd470bd-4f3a-4ac9-8b21-3106daec0c9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: SYRUP
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA202940
Marketing category: ANDA
Marketing start: 2014-07-21
Marketing end: 2020-10-31
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64376-657		D	Discontinued by firm	2026-08-03
excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	2026-08-03
excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	64376-657		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	64376-657		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	64376-657		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	64376-657		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	64376-657		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64376-657	64376-657-16	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64376-657	64376-657-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`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
A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA		2014-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202940-001	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	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	2014-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202940-001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		2014-07-21	`cb3db0bc1861…`

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	A202940-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202940-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202940-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202940-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202940-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202940-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202940-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202940-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202940-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202940-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202940-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202940-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202940-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202940-001	AA	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A202940-001	AA	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A202940-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202940-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202940-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202940-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202940-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202940-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202940-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202940-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202940-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202940-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202940-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202940-001	AA	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202940-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 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	PAI Holdings, LLC dba PAI Pharma	01ea6357-24dc-4056-9fd2-9e643650b91f	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202940 application number: ANDA202940

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64376-657-16	ML - Milliliter	64376-657	587819f5-a73d-47e5-b748-b2b7219ed351	1	2014-09-03
64376-657-40	ML - Milliliter	64376-657	7ccca919-2ab0-4934-ac23-b2193eaaaacb	1	2014-09-03

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 [BOCA PHARMACAL, LLC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BOCA PHARMACAL, LLC]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup	Par Pharmaceutical \| Sovereign Pharmaceuticals, LLC	2018-03-14	HUMAN PRESCRIPTION DRUG LABEL	5