FDA.reportPublic FDA data

Mucus Relief

Product NDC
54738-981
11-digit product format
547380981
Labeler code
54738
Product ID
54738-981_5cc3bf1b-4684-6a53-e053-2a91aa0abfa6
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400 mg
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-03-01
Substance
GUAIFENESIN
Active strength
400 mg/1
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
2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26924bee-32cc-4499-beb0-2650ff8eb1daAvailable 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
54738-981-30Mucus Relief30 in 1 BOTTLETABLET302
54738-981-60Mucus Relief60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-981-30EA - Each54738-981ed28af0a-7872-42d0-bcfb-ef0fc05623a712018-05-09
54738-981-60EA - Each54738-9817be0902c-a6f6-42ba-a4df-c834b96f056f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-981MUCUS RELIEF (GUAIFENESIN 400 MG) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20171030_26924bee-32cc-4499-beb0-2650ff8eb1da.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 ReliefGUAIFENESIN 400 MGRichmond Pharmaceuticals, Inc.26924bee-32cc-4499-beb0-2650ff8eb1da2017-10-30WarningsExact identifier
ndc (product): 54738-981

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN26924bee-32cc-4499-beb0-2650ff8eb1da2
359601guaifenesin 400 MG Oral TabletSCD26924bee-32cc-4499-beb0-2650ff8eb1da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-981-305473809813030 TABLET in 1 BOTTLE (54738-981-30) 30 tablet2016-03-010000-00-00NoNoCurrent
54738-981-605473809816060 TABLET in 1 BOTTLE (54738-981-60) 60 tablet2016-03-010000-00-00NoNoCurrent