FDA.reportPublic FDA data

mucus and chest congestion

Product NDC
41250-507
Requested package NDC
41250-507-34
11-digit product format
412500507
Labeler code
41250
Product ID
41250-507_7c92afa0-dd2a-43c9-bf5a-9ea9db475420
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-15
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
200 mg/10mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage41250-50741250-507-34DDiscontinued 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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
41250-507-34ML - Milliliter41250-507effb23e6-4e26-4e49-b7b5-385f37615c6612024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
MALTOLINACTIVE INGREDIENT3A9RD92BS4MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RMUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [MEIJER DISTRIBUTION INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-507-34412500507341 BOTTLE in 1 CARTON (41250-507-34) > 237 mL in 1 BOTTLE1 bottle2014-07-150000-00-00NoNoCurrent