FDA.reportPublic FDA data

Mucus Relief DM MAXIMUM STRENGTH

Product NDC
21130-989
11-digit product format
211300989
Labeler code
21130
Product ID
21130-989_91782655-a29b-4bda-b514-5489279b3edb
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
60; 1200 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 MAXIMUM STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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
21130-989-03Mucus Relief DM MAXIMUM STRENGTH7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE79
21130-989-03Mucus Relief DM MAXIMUM STRENGTH4 in 1 CARTONTABLET, EXTENDED RELEASE49
21130-989-65Mucus Relief DM MAXIMUM STRENGTH7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE79
21130-989-65Mucus Relief DM MAXIMUM STRENGTH2 in 1 CARTONTABLET, EXTENDED RELEASE29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-989MUCUS RELIEF DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS LLC]8Current NDC, Legacy NDC, 4 package rows20240210_4ee69f46-3dc6-4249-9b04-186fa0a13e84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN4ee69f46-3dc6-4249-9b04-186fa0a13e849
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD4ee69f46-3dc6-4249-9b04-186fa0a13e849
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY4ee69f46-3dc6-4249-9b04-186fa0a13e849

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-989-03211300989034 BLISTER PACK in 1 CARTON (21130-989-03) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2022-04-280000-00-00NoNoCurrent
21130-989-65211300989652 BLISTER PACK in 1 CARTON (21130-989-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent