FDA.reportPublic FDA data

Good Sense Mucus DM

Product NDC
0113-2219
11-digit product format
001132219
Labeler code
0113
Product ID
0113-2219_f0ac347e-3a85-455a-9578-eaaf65c32d12
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA207602
Marketing category
ANDA
Marketing start
2019-07-10
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
Good Sense Mucus 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-2219-01Good Sense Mucus DM20 in 1 BOTTLETABLET, EXTENDED RELEASE204
0113-2219-01Good Sense Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE14
0113-2219-49Good Sense Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE14
0113-2219-49Good Sense Mucus DM40 in 1 BOTTLETABLET, EXTENDED RELEASE404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-2219-01EA - Each0113-2219b0256d15-448c-41aa-9847-3b991fcd608c12022-05-04
0113-2219-49EA - Each0113-2219d24588a1-41a9-4bfd-9e76-6e027330485a12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-2219GOOD SENSE MUCUS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 4 package rows20230726_34f26b33-af34-470a-b57e-921fbdcbd9af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN34f26b33-af34-470a-b57e-921fbdcbd9af4
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD34f26b33-af34-470a-b57e-921fbdcbd9af4
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY34f26b33-af34-470a-b57e-921fbdcbd9af4
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN81fb0ce7-1b13-4b9d-8f98-671ffd9205c31
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD81fb0ce7-1b13-4b9d-8f98-671ffd9205c31
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY81fb0ce7-1b13-4b9d-8f98-671ffd9205c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-2219-01001132219011 BOTTLE in 1 CARTON (0113-2219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
0113-2219-49001132219491 in 1 CARTONHistorical