FDA.reportPublic FDA data

MUCUS RELIEF

Product NDC
41226-272
Requested package NDC
41226-272-03
11-digit product format
412260272
Labeler code
41226
Product ID
41226-272_88f1545a-6dbd-54f8-e053-2995a90a4138
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-06-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MUCUS RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
813b1db2-a177-77c6-e053-2a91aa0ac73bAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-272-03MUCUS RELIEF30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-272MUCUS RELIEF (GUAIFENESIN) TABLET [KROGER COMPANY]2Current NDC, Legacy NDC, 1 package rows20190603_813b1db2-a177-77c6-e053-2a91aa0ac73b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2023-01-17WarningsExact identifier
ndc (package): 41226-272-03
ndc (product): 41226-272
ndc11 (package): 41226027203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN813b1db2-a177-77c6-e053-2a91aa0ac73b2
359601guaifenesin 400 MG Oral TabletSCD813b1db2-a177-77c6-e053-2a91aa0ac73b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-272-034122602720330 TABLET in 1 BOTTLE (41226-272-03) 30 tablet2019-06-030000-00-00NoNoCurrent