FDA.reportPublic FDA data

Mucus Relief

Product NDC
50804-857
Requested package NDC
50804-857-30
11-digit product format
508040857
Labeler code
50804
Product ID
50804-857_b0f5dd3a-9b14-456f-9540-790cdb0b8640
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-28
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
400 mg/1
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 packagepackage50804-85750804-857-30DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-857-302023-02-11C16284748780-1f386c64a-1e96-0266-e053-dadaa90a7c1aDrug Facts
50804-857-302023-01-30C16284748780-1f386c64a-1e96-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-857-30Mucus Relief1 in 1 BOXTABLET14
50804-857-30Mucus Relief30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-857MUCUS RELIEF (GUAIFENESIN) TABLET [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]3Legacy NDC, 2 package rows20240404_552b0c0e-00f9-498b-8786-ad242703e04b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN552b0c0e-00f9-498b-8786-ad242703e04b4
359601guaifenesin 400 MG Oral TabletSCD552b0c0e-00f9-498b-8786-ad242703e04b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-857-30508040857301 BOTTLE, PLASTIC in 1 BOX (50804-857-30) > 30 TABLET in 1 BOTTLE, PLASTIC2020-02-280000-00-00NoNoCurrent