mucus relief dm

Product NDC
41250-436
11-digit product format
412500436
Labeler code
41250
Product ID
41250-436_72597fb2-a000-47ad-9672-392c5db34c44
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA207602
Marketing category
ANDA
Marketing start
2020-06-02
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
41250-436-01mucus relief dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
41250-436-01mucus relief dm20 in 1 BOTTLETABLET, EXTENDED RELEASE203
41250-436-49mucus relief dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
41250-436-49mucus relief dm40 in 1 BOTTLETABLET, EXTENDED RELEASE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-436MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [MEIJER DISTRIBUTION INC]3Current NDC, Legacy NDC, 4 package rows20250514_d41749b4-735b-44f7-ab06-244f68e031e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNd41749b4-735b-44f7-ab06-244f68e031e33
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDd41749b4-735b-44f7-ab06-244f68e031e33
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYd41749b4-735b-44f7-ab06-244f68e031e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-436-01412500436011 BOTTLE in 1 CARTON (41250-436-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-06-020000-00-00NoNoCurrent
41250-436-49412500436491 BOTTLE in 1 CARTON (41250-436-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-06-020000-00-00NoNoCurrent