Mucus Relief DM Extended Release Caplets

Product NDC
55910-634
11-digit product format
559100634
Labeler code
55910
Product ID
55910-634_1b9744e4-75a9-44e3-96c1-2c0d117bd206
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA209692
Marketing category
ANDA
Marketing start
2019-02-28
Marketing end
2026-05-28
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-634MUCUS RELIEF DM EXTENDED RELEASE CAPLETS MAXIMUM STRENGTH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]5Current NDC, Legacy NDC20221108_62cd2d77-abcb-4848-8d17-cf8c67216373.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-634-07559100634077 BLISTER PACK in 1 CARTON (55910-634-07) / 1 TABLET in 1 BLISTER PACK7 blister pack2019-02-282026-05-28NoNoCurrent
55910-634-145591006341414 BLISTER PACK in 1 CARTON (55910-634-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2019-02-282026-05-28NoNoCurrent