Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide

Product NDC: 63187-400
11-digit product format: 631870400
Labeler code: 63187
Product ID: 63187-400_7f00edf4-7b75-4ba8-9685-5f7c6326d0ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA088811
Marketing category: ANDA
Marketing start: 2010-06-15
Marketing end: 0000-00-00
Substance: BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-400		D	Discontinued by firm		2026-10-05
excluded package	package	63187-400	63187-400-04	D	Discontinued by firm		2026-10-05

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
A088811-001	BROMFED-DM	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		RLD	1985-06-07

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		RLD	1985-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		RLD	1985-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL		RLD	1985-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RLD	1985-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088811-001	BROMFED-DM	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP / ORAL	AA	RS	1985-06-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088811-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088811-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088811-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088811-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088811-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088811-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088811-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088811-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088811-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088811-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088811-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088811-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088811-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088811-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088811-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088811-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088811-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088811-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088811-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088811-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088811-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088811-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088811-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088811-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088811-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088811-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088811-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088811-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088811-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088811-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088811-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088811-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088811-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088811-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088811-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088811-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088811-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088811-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088811-001	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Brompheniramine Maleate	ACTIVE INGREDIENT	IXA7C9ZN03	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Brompheniramine	ACTIVE MOIETY	H57G17P2FN	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-400	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]	3	Legacy NDC	20200515_871632bb-0525-4e3b-a3ab-a50393bc9634.zip

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	Marketing end	Sample	Exclude flag	Status
63187-400-04	63187040004	118 mL in 1 BOTTLE, PLASTIC (63187-400-04)	118 ml	2019-01-01	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 2 mg/30 mg/10 mg per 5 mL	Proficient Rx LP	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	3