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 Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1147685

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

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