FDA.reportPublic FDA data

MUCUS RELIEF

Product NDC
68210-6110
11-digit product format
682106110
Labeler code
68210
Product ID
68210-6110_ee515a9d-9b12-ca05-e053-2a95a90ab099
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
2020-03-10
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-6110IInactivated by FDA2026-10-20
excluded packagepackage68210-611068210-6110-2IInactivated by FDA2026-10-20
excluded packagepackage68210-611068210-6110-3IInactivated by FDA2026-10-20

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-6110-2MUCUS RELIEF200 in 1 PACKAGETABLET2008
68210-6110-3MUCUS RELIEF30 in 1 BOTTLETABLET308
68210-6110-3MUCUS RELIEF1 in 1 CARTONTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-6110MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC]8Legacy NDC, 3 package rows20241215_fb71526e-b9a4-419c-94e8-0510dddf0b19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNfb71526e-b9a4-419c-94e8-0510dddf0b198
359601guaifenesin 400 MG Oral TabletSCDfb71526e-b9a4-419c-94e8-0510dddf0b198

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-6110-168210611001120 TABLET in 1 BOTTLE (68210-6110-1) 120 tablet2020-04-060000-00-00NoNoCurrent
68210-6110-268210611002200 TABLET in 1 PACKAGE (68210-6110-2) 200 tablet2020-03-120000-00-00NoNoCurrent
68210-6110-3682106110031 BOTTLE in 1 CARTON (68210-6110-3) > 30 TABLET in 1 BOTTLE1 bottle2020-03-100000-00-00NoNoCurrent