Medique Guaicon DMS

Product NDC
47682-217
11-digit product format
476820217
Labeler code
47682
Product ID
47682-217_da5774c5-4bf0-c136-e053-2995a90aa1e9
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan Hbr
Dosage form
SYRUP
Route
ORAL
Labeler
UNIFIRST FIRST AID CORPORATION
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-05
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct47682-217DDiscontinued by firm2026-10-12
excluded packagepackage47682-21747682-217-71DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47682-217-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47682-217-71f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47682-217-712ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47682-217-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47682-217-71cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47682-217-71cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47682-217-71302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47682-217-71ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47682-217-710efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47682-217-71ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage47682-217-71367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage47682-217-71557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-217-71ML - Milliliter47682-217ea8a6b68-0df6-4d2a-b513-aaa39eade8f012017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
GUAIFENESINACTIVE INGREDIENT495W7451VQMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
GUAIFENESINACTIVE MOIETY495W7451VQMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RMEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-217-714768202177120 PACKET in 1 BOX (47682-217-71) > 10 mL in 1 PACKET20 packet2011-04-050000-00-00NoNoCurrent