Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
24451-133
11-digit product format
244510133
Labeler code
24451
Product ID
24451-133_119a9192-39fa-47d6-b277-eb0ff6ce87db
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
LLC Federal Solutions
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-08
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24451-133DDiscontinued by firm2026-10-05
excluded packagepackage24451-13324451-133-05DDiscontinued by firm2026-10-05
excluded packagepackage24451-13324451-133-10DDiscontinued by firm2026-10-05

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 · 39 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 packagepackage24451-133-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24451-133-10DDiscontinued 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 packagepackage24451-133-05DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24451-133-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24451-133-10IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24451-133-05IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
SORBITOLINACTIVE INGREDIENT506T60A25RGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS]1