Broncotron PED

Product NDC
11026-2790
Requested package NDC
11026-2790-2
11-digit product format
110262790
Labeler code
11026
Product ID
11026-2790_244c2ce8-78b6-4179-8a56-d6d8031fafe0
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Seyer Pharmatec, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-12-15
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL; mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11026-279011026-2790-2DDiscontinued by firm2026-10-12

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 · 14 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11026-2790-22020-12-23C16284748780-19d75b9d0-b4ac-f424-e053-dadaa90a57ceDrug Facts
11026-2790-22020-01-31C16284748780-19d75b9d0-b4ac-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11026-2790-2ML - Milliliter11026-279068b3f7c6-a36f-4d33-8a2b-d714579beeb312013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBRONCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [SEYER PHARMATEC, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11026-2790-2110262790021 BOTTLE, DROPPER in 1 CARTON (11026-2790-2) > 60 mL in 1 BOTTLE, DROPPER2012-12-150000-00-00NoNoCurrent