FDA.reportPublic FDA data

mucus relief dm

Product NDC
0363-6812
11-digit product format
003636812
Labeler code
0363
Product ID
0363-6812_549ab761-1242-4bd8-8307-67aed29bc26e
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-12-21
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
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
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
0363-6812-30mucus relief dm1 in 1 CARTONTABLET, EXTENDED RELEASE12
0363-6812-30mucus relief dm28 in 1 BOTTLETABLET, EXTENDED RELEASE282
0363-6812-55mucus relief dm42 in 1 BOTTLETABLET, EXTENDED RELEASE422
0363-6812-55mucus relief dm1 in 1 CARTONTABLET, EXTENDED RELEASE12
0363-6812-66mucus relief dm14 in 1 BOTTLETABLET, EXTENDED RELEASE142
0363-6812-66mucus relief dm1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6812MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2Current NDC, Legacy NDC, 6 package rows20240418_ba200f15-56dd-4b4d-9f3f-1340f3cb73a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNba200f15-56dd-4b4d-9f3f-1340f3cb73a52
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDba200f15-56dd-4b4d-9f3f-1340f3cb73a52
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYba200f15-56dd-4b4d-9f3f-1340f3cb73a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6812-30003636812301 BOTTLE in 1 CARTON (0363-6812-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-01-070000-00-00NoNoCurrent
0363-6812-55003636812551 BOTTLE in 1 CARTON (0363-6812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-12-210000-00-00NoNoCurrent
0363-6812-66003636812661 BOTTLE in 1 CARTON (0363-6812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-01-070000-00-00NoNoCurrent