FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
37808-733
11-digit product format
378080733
Labeler code
37808
Product ID
37808-733_d2aca5b5-2bb6-41b5-a614-f470d233c98e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H E B
Application
ANDA209692
Marketing category
ANDA
Marketing start
2023-02-28
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
37808-733-20Mucus Relief DM1 in 1 BOXTABLET, EXTENDED RELEASE13
37808-733-20Mucus Relief DM20 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE203
37808-733-40Mucus Relief DM1 in 1 BOXTABLET, EXTENDED RELEASE13
37808-733-40Mucus Relief DM40 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-733MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [H E B]3Current NDC, 4 package rows20240805_bcc41783-9213-4a8e-b7db-75b4da08551d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNbcc41783-9213-4a8e-b7db-75b4da08551d3
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDbcc41783-9213-4a8e-b7db-75b4da08551d3
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYbcc41783-9213-4a8e-b7db-75b4da08551d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
37808-733-20378080733201 BOTTLE, PLASTIC in 1 BOX (37808-733-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2023-02-28NoNoCurrent
37808-733-40378080733401 BOTTLE, PLASTIC in 1 BOX (37808-733-40) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2023-02-28NoNoCurrent