Bromfed DM

Product NDC: 60432-837
11-digit product format: 604320837
Labeler code: 60432
Product ID: 60432-837_96641a48-5450-44bb-a1ab-25d0cf05f2a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Morton Grove Pharmaceuticals, Inc.
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: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60432-837		D	Discontinued by firm	2026-10-05
excluded package	package	60432-837	60432-837-04	D	Discontinued by firm	2026-10-05
excluded package	package	60432-837	60432-837-15	D	Discontinued by firm	2026-10-05
excluded package	package	60432-837	60432-837-16	D	Discontinued by firm	2026-10-05

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60432-837-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60432-837-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60432-837-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60432-837-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60432-837-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60432-837-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60432-837-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60432-837-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60432-837-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60432-837-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60432-837-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60432-837-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60432-837-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60432-837-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60432-837-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60432-837-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60432-837-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60432-837-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60432-837-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60432-837-04	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60432-837-15	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60432-837-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60432-837-04	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60432-837-15	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60432-837-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60432-837-04	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60432-837-15	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60432-837-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60432-837-04	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60432-837-15	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60432-837-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60432-837-04	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60432-837-15	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60432-837-16	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60432-837-04	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60432-837-15	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60432-837-16	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60432-837-04	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60432-837-16	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60432-837-04	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60432-837-16	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60432-837-04	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
60432-837-04	2025-11-14	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only
60432-837-15	2025-11-14	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only
60432-837-16	2025-11-14	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only
60432-837-04	2023-01-30	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only
60432-837-15	2023-01-30	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only
60432-837-16	2023-01-30	BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-837-04	ML - Milliliter	60432-837	dd90841a-bf1d-43d6-a161-ef1dec1be26a	1	2012-07-24
60432-837-16	ML - Milliliter	60432-837	98c39b24-f8ba-4a18-b1cd-bafa9d4d020b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Brompheniramine Maleate	ACTIVE INGREDIENT	IXA7C9ZN03	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Brompheniramine	ACTIVE MOIETY	H57G17P2FN	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Alcohol	INACTIVE INGREDIENT	3K9958V90M	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	7
Brompheniramine Maleate	ACTIVE INGREDIENT	IXA7C9ZN03	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
Brompheniramine	ACTIVE MOIETY	H57G17P2FN	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-837	BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	12	Legacy NDC	20210112_e241d83e-996c-494d-b3fe-97f1ef4809ed.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1358993	Bromfed DM 2 MG / 10 MG / 30 MG in 5 mL Oral Solution	PSN	ccdf22f3-171f-4c19-8273-fefa140d1969	1
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	ccdf22f3-171f-4c19-8273-fefa140d1969	1
1358993	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution [Bromfed DM]	SBD	ccdf22f3-171f-4c19-8273-fefa140d1969	1
1357010	brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	ccdf22f3-171f-4c19-8273-fefa140d1969	1
1358993	Bromfed DM (brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 30 MG) per 5 ML Oral Solution	SY	ccdf22f3-171f-4c19-8273-fefa140d1969	1
1357010	brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	ccdf22f3-171f-4c19-8273-fefa140d1969	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60432-837-04	60432083704	118 mL in 1 BOTTLE, PLASTIC (60432-837-04)	118 ml	2010-06-15	0000-00-00	No	No	Current
60432-837-16	60432083716	473 mL in 1 BOTTLE, PLASTIC (60432-837-16)	473 ml	2010-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bromfed DM	Morton Grove Pharmaceuticals, Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	12
BROMFED ® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg)	Physicians Total Care, Inc.	2013-02-05	HUMAN PRESCRIPTION DRUG LABEL	1