FDA.reportPublic FDA data

Mucus Relief Cough and Congestion DM

Product NDC
54738-985
11-digit product format
547380985
Labeler code
54738
Product ID
54738-985_5cc409a8-23e1-738f-e053-2a91aa0ac0d5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Cough and Congestion DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59b00858-e5c9-420a-bc7e-46953722cde6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-985-30Mucus Relief Cough and Congestion DM30 in 1 BOTTLETABLET302
54738-985-60Mucus Relief Cough and Congestion DM60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-985-30EA - Each54738-98518e8121c-ba1e-44f7-a28f-4f04f4a3097512017-11-06
54738-985-60EA - Each54738-98543630cc1-5000-4ee0-a935-6abdb7aaa76912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-985MUCUS RELIEF COUGH AND CONGESTION DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [RICHMOND PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 2 package rows20171030_59b00858-e5c9-420a-bc7e-46953722cde6.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 Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
ndc (product): 54738-985

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN8c25285e-e2cd-4e10-af63-5dce8098b615101
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD8c25285e-e2cd-4e10-af63-5dce8098b615101
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY8c25285e-e2cd-4e10-af63-5dce8098b615101
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN59b00858-e5c9-420a-bc7e-46953722cde62
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD59b00858-e5c9-420a-bc7e-46953722cde62
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY59b00858-e5c9-420a-bc7e-46953722cde62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-985-305473809853030 TABLET in 1 BOTTLE (54738-985-30) 30 tablet2016-04-010000-00-00NoNoCurrent
54738-985-605473809856060 TABLET in 1 BOTTLE (54738-985-60) 60 tablet2016-04-010000-00-00NoNoCurrent