Broncotron

Product NDC
11026-2650
11-digit product format
110262650
Labeler code
11026
Product ID
11026-2650_9146a6b6-cbaf-4304-b52f-6e6251b3f350
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
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
Active strength
20 mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11026-2650DDiscontinued by firm2026-10-12
excluded packagepackage11026-265011026-2650-4DDiscontinued 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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11026-2650-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11026-2650-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11026-2650-4DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11026-2650-4DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11026-2650-4DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11026-2650-4DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11026-2650-4DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11026-2650-4DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11026-2650-4DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11026-2650-4DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11026-2650-4DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11026-2650-4DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11026-2650-4IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11026-2650-4IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11026-2650-4IInactivated by FDA110d247fa046…a55b01930146…

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
11026-2650-42021-10-21C16284748780-19855d018-e9e7-cd31-e053-dbdaa90ab51aDrug Facts
11026-2650-42019-11-27C16284748780-19855d018-e9e7-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11026-2650-4ML - Milliliter11026-26503e7a6ff9-5be4-4ebb-8c08-f47cd2def75812013-07-02

DailyMed Socrata Ingredients#

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