Home NDC 68788-7554 Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Product NDC 68788-7554
11-digit product format 687887554
Labeler code 68788
Product ID 68788-7554_8c6d9057-412e-4ad2-83d5-7afe4bf6d35a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form SYRUP
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA088811
Marketing category ANDA
Marketing start 2010-06-15
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-7554-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-7554-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68788-7554-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68788-7554-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68788-7554-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68788-7554-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-7554-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-7554-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7554-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68788-7554-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68788-7554-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68788-7554-1 557ba5c1ecfa…9c80585c8c6e…
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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7554-1 68788755401 118 mL in 1 BOTTLE, PLASTIC (68788-7554-1) 118 ml 2010-06-15 0000-00-00 No No Current