Mucus Relief DM Extended Release Caplets

Product NDC
0363-0733
11-digit product format
003630733
Labeler code
0363
Product ID
0363-0733_e89d2575-c3c1-4633-866c-cecba7d52370
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA209692
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
2027-01-01
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM Extended Release Caplets

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
0363-0733-20Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET15
0363-0733-20Mucus Relief DM Extended Release Caplets20 in 1 CARTONTABLET205
0363-0733-40Mucus Relief DM Extended Release Caplets40 in 1 CARTONTABLET405
0363-0733-40Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0733MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [WALGREENS]4Current NDC, Legacy NDC, 4 package rows20230810_be5ab61a-abd6-4dee-9607-2f1e2c47b2dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNbe5ab61a-abd6-4dee-9607-2f1e2c47b2dc5
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDbe5ab61a-abd6-4dee-9607-2f1e2c47b2dc5
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYbe5ab61a-abd6-4dee-9607-2f1e2c47b2dc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0733-200036307332020 BLISTER PACK in 1 CARTON (0363-0733-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2019-01-012027-01-01NoNoCurrent
0363-0733-400036307334040 BLISTER PACK in 1 CARTON (0363-0733-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2019-01-012027-01-01NoNoCurrent