FDA.reportPublic FDA data

Maximum Strength Mucus Relief DM

Product NDC
49035-956
11-digit product format
490350956
Labeler code
49035
Product ID
49035-956_2a47b570-28c7-480f-b829-a714432c803b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-956-61Maximum Strength Mucus Relief DM28 in 1 BOTTLETABLET, EXTENDED RELEASE286
49035-956-61Maximum Strength Mucus Relief DM1 in 1 CARTONTABLET, EXTENDED RELEASE16
49035-956-65Maximum Strength Mucus Relief DM14 in 1 BOTTLETABLET, EXTENDED RELEASE146
49035-956-65Maximum Strength Mucus Relief DM1 in 1 CARTONTABLET, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-956-65EA - Each49035-95648cd9cbf-6f6c-4170-b81d-53f29672309b12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-956MAXIMUM STRENGTH MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [WAL-MART STORES, INC.]6Current NDC, Legacy NDC, 4 package rows20240210_ff7280e7-804b-423d-add8-54ec2c76fca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNff7280e7-804b-423d-add8-54ec2c76fca26
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDff7280e7-804b-423d-add8-54ec2c76fca26
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYff7280e7-804b-423d-add8-54ec2c76fca26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-956-61490350956611 BOTTLE in 1 CARTON (49035-956-61) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
49035-956-65490350956651 BOTTLE in 1 CARTON (49035-956-65) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent