FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
0363-0474
11-digit product format
003630474
Labeler code
0363
Product ID
0363-0474_bce2f870-cc8b-4560-9bdb-d83b0788e5d6
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
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
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
0363-0474-012024-01-30C16284748780-11030e365-3744-111a-e063-dadaa90a10e2Drug Facts
0363-0474-672024-01-30C16284748780-11030e365-3744-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0474-01Mucus Relief DM4 in 1 CARTONTABLET, EXTENDED RELEASE49
0363-0474-01Mucus Relief DM10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
0363-0474-67Mucus Relief DM10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
0363-0474-67Mucus Relief DM2 in 1 CARTONTABLET, EXTENDED RELEASE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0474-01EA - Each0363-0474a0b9d216-23a6-4b2a-a97f-25a2aff875f812022-06-06
0363-0474-67EA - Each0363-0474a401a4f2-4040-4506-8bab-0747ff0483e712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0474MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [WALGREEN CO.]9Current NDC, Legacy NDC, 4 package rows20240210_40264f92-677e-481e-8d78-5577b2979b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN40264f92-677e-481e-8d78-5577b2979b019
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD40264f92-677e-481e-8d78-5577b2979b019
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY40264f92-677e-481e-8d78-5577b2979b019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0474-01003630474014 BLISTER PACK in 1 CARTON (0363-0474-01) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-170000-00-00NoNoCurrent
0363-0474-67003630474672 BLISTER PACK in 1 CARTON (0363-0474-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent