FDA.reportPublic FDA data

DG health mucus dm

Product NDC
55910-575
11-digit product format
559100575
Labeler code
55910
Product ID
55910-575_2a65e578-eefd-4d1e-ad97-08939a044ebe
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-07-02
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
DG health mucus 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
55910-575-03DG health mucus dm7 in 1 CARTONTABLET, EXTENDED RELEASE73
55910-575-03DG health mucus dm1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
55910-575-66DG health mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
55910-575-66DG health mucus dm14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-575DG HEALTH MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 4 package rows20221130_add72ca5-94cd-437f-b30f-6149c08b5f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNadd72ca5-94cd-437f-b30f-6149c08b5f213
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDadd72ca5-94cd-437f-b30f-6149c08b5f213
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYadd72ca5-94cd-437f-b30f-6149c08b5f213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-575-03559100575037 BLISTER PACK in 1 CARTON (55910-575-03) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK7 blister pack2022-11-030000-00-00NoNoCurrent
55910-575-66559100575661 BOTTLE in 1 CARTON (55910-575-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-07-020000-00-00NoNoCurrent