FDA.reportPublic FDA data

MUCUS RELIEF

Product NDC
68210-4102
Requested package NDC
68210-4102-5
11-digit product format
682104102
Labeler code
68210
Product ID
68210-4102_d20605f5-58eb-6e61-e053-2a95a90a320b
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
400 mg/1
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 packagepackage68210-410268210-4102-5IInactivated by FDA2026-10-05

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, Related label table
NDCEffectiveRelated label
68210-4102-12026-01-29Guaifenesin 400mg
68210-4102-22026-01-29Guaifenesin 400mg
68210-4102-52026-01-29Guaifenesin 400mg
68210-4102-12023-12-07Guaifenesin 400mg
68210-4102-22023-12-07Guaifenesin 400mg
68210-4102-52023-12-07Guaifenesin 400mg
68210-4102-12023-01-30Guaifenesin 400mg
68210-4102-22023-01-30Guaifenesin 400mg
68210-4102-52023-01-30Guaifenesin 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4102-1MUCUS RELIEF200 in 1 BOTTLETABLET2006
68210-4102-2MUCUS RELIEF50 in 1 PACKAGETABLET506
68210-4102-5MUCUS RELIEF150 in 1 BOTTLETABLET1506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4102MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 3 package rows20241215_d2ab3a1d-6b47-4b4e-b47a-eee79eac2a1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNd2ab3a1d-6b47-4b4e-b47a-eee79eac2a1e6
359601guaifenesin 400 MG Oral TabletSCDd2ab3a1d-6b47-4b4e-b47a-eee79eac2a1e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4102-568210410205150 TABLET in 1 BOTTLE (68210-4102-5) 150 tablet2020-10-070000-00-00NoNoCurrent