Maximum Strength Mucus Relief DM

Product NDC
0363-0510
11-digit product format
003630510
Labeler code
0363
Product ID
0363-0510_12933549-899f-44ac-be98-afc7feb3e95e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maximum Strength Mucus Relief DM
Listing expiration
2026-12-31

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0510-652024-01-30C16284748780-11030e365-3478-111a-e063-dadaa90a10e2Drug Facts
0363-0510-702024-01-30C16284748780-11030e365-3478-111a-e063-dadaa90a10e2Drug Facts
0363-0510-992024-01-30C16284748780-11030e365-3478-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0510-65Maximum Strength Mucus Relief DM7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE79
0363-0510-65Maximum Strength Mucus Relief DM2 in 1 CARTONTABLET, EXTENDED RELEASE29
0363-0510-70Maximum Strength Mucus Relief DM7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE79
0363-0510-70Maximum Strength Mucus Relief DM4 in 1 CARTONTABLET, EXTENDED RELEASE49
0363-0510-99Maximum Strength Mucus Relief DM7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE79
0363-0510-99Maximum Strength Mucus Relief DM6 in 1 CARTONTABLET, EXTENDED RELEASE69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0510MAXIMUM STRENGTH MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [WALGREEN CO.]9Current NDC, Legacy NDC, 6 package rows20240210_83483b91-77e5-42ca-a467-21312ef32d30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN83483b91-77e5-42ca-a467-21312ef32d309
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD83483b91-77e5-42ca-a467-21312ef32d309
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY83483b91-77e5-42ca-a467-21312ef32d309

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0510-65003630510652 BLISTER PACK in 1 CARTON (0363-0510-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent
0363-0510-70003630510704 BLISTER PACK in 1 CARTON (0363-0510-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-170000-00-00NoNoCurrent
0363-0510-99003630510996 BLISTER PACK in 1 CARTON (0363-0510-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2017-03-170000-00-00NoNoCurrent