MUCUS RELIEF DM

Product NDC
21130-997
11-digit product format
211300997
Labeler code
21130
Product ID
21130-997_3bbe6c7f-d315-433f-a23d-b3b97041996f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Better Living Brands LLC
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

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
21130-997-67MUCUS RELIEF DM2 in 1 CARTONTABLET, EXTENDED RELEASE29
21130-997-67MUCUS RELIEF DM10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-997MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS LLC]8Current NDC, Legacy NDC, 2 package rows20240210_dca1d482-062f-4915-b0a7-c00ab47aaff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNdca1d482-062f-4915-b0a7-c00ab47aaff89
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDdca1d482-062f-4915-b0a7-c00ab47aaff89
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYdca1d482-062f-4915-b0a7-c00ab47aaff89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-997-67211300997672 BLISTER PACK in 1 CARTON (21130-997-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent