FDA.reportPublic FDA data

Mucus Relief DM Extended Release Caplets

Product NDC
0363-0437
11-digit product format
003630437
Labeler code
0363
Product ID
0363-0437_fd5e4fe2-3fe7-4277-8bd3-fc955c259714
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
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
Current FDA listing
Yes

Additional Listing Data#

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

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0363-0437-14Mucus Relief DM Extended Release CapletsMaximum Strength1 in 1 BLISTER PACKTABLET15
0363-0437-14Mucus Relief DM Extended Release CapletsMaximum Strength14 in 1 CARTONTABLET145
0363-0437-28Mucus Relief DM Extended Release CapletsMaximum Strength28 in 1 CARTONTABLET285
0363-0437-28Mucus Relief DM Extended Release CapletsMaximum Strength1 in 1 BLISTER PACKTABLET15
0363-0437-42Mucus Relief DM Extended Release CapletsMaximum Strength42 in 1 CARTONTABLET425
0363-0437-42Mucus Relief DM Extended Release CapletsMaximum Strength1 in 1 BLISTER PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0437MUCUS RELIEF DM EXTENDED RELEASE CAPLETS MAXIMUM STRENGTH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [WALGREENS]4Current NDC, Legacy NDC, 6 package rows20230810_11310cf8-ea34-47a2-b4d7-fe1131fef462.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN11310cf8-ea34-47a2-b4d7-fe1131fef4625
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD11310cf8-ea34-47a2-b4d7-fe1131fef4625
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY11310cf8-ea34-47a2-b4d7-fe1131fef4625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0437-140036304371414 BLISTER PACK in 1 CARTON (0363-0437-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2019-01-012027-01-01NoNoCurrent
0363-0437-280036304372828 BLISTER PACK in 1 CARTON (0363-0437-28) / 1 TABLET in 1 BLISTER PACK28 blister pack2019-01-012027-01-01NoNoCurrent
0363-0437-420036304374242 BLISTER PACK in 1 CARTON (0363-0437-42) / 1 TABLET in 1 BLISTER PACK42 blister pack2019-01-012027-01-01NoNoCurrent