FDA.reportPublic FDA data

mucus dm extended release

Product NDC
69842-963
11-digit product format
698420963
Labeler code
69842
Product ID
69842-963_e6de3982-4439-4272-9d2c-60d88236f877
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin, dextromethorphan hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207602
Marketing category
ANDA
Marketing start
2019-09-13
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 dm extended release
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
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
69842-963-01mucus dm extended release1 in 1 CARTONTABLET, EXTENDED RELEASE14
69842-963-01mucus dm extended release20 in 1 BOTTLETABLET, EXTENDED RELEASE204
69842-963-49mucus dm extended release40 in 1 BOTTLETABLET, EXTENDED RELEASE404
69842-963-49mucus dm extended release1 in 1 CARTONTABLET, EXTENDED RELEASE14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN6c9540ae-aea1-4717-8dca-60850ebdb1b44
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD6c9540ae-aea1-4717-8dca-60850ebdb1b44
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY6c9540ae-aea1-4717-8dca-60850ebdb1b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-963-01698420963011 BOTTLE in 1 CARTON (69842-963-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-09-130000-00-00NoNoCurrent
69842-963-49698420963491 BOTTLE in 1 CARTON (69842-963-49) > 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-09-130000-00-00NoNoCurrent