FDA.reportPublic FDA data

good sense mucus dm

Product NDC
0113-0812
11-digit product format
001130812
Labeler code
0113
Product ID
0113-0812_6e835260-03c9-4340-a872-f049c8ea5c96
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
L Perrigo Company
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-06-21
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
good sense 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
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
0113-0812-03good sense mucus dm7 in 1 CARTONTABLET, EXTENDED RELEASE73
0113-0812-03good sense mucus dm1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
0113-0812-66good sense mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE13
0113-0812-66good sense mucus dm14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0812-03EA - Each0113-08121941cdca-a90f-4393-a487-432e60e6d88112024-02-14
0113-0812-66EA - Each0113-081297ba9223-accf-4053-ae7b-3928efd6490512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0812GOOD SENSE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [L PERRIGO COMPANY]2Current NDC, Legacy NDC, 4 package rows20211007_654dc991-1984-43cc-a00e-0c85d910b323.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN654dc991-1984-43cc-a00e-0c85d910b3233
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD654dc991-1984-43cc-a00e-0c85d910b3233
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY654dc991-1984-43cc-a00e-0c85d910b3233
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN9995f480-da71-4e3b-8154-9eefaeb9299d1
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD9995f480-da71-4e3b-8154-9eefaeb9299d1
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY9995f480-da71-4e3b-8154-9eefaeb9299d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0812-03001130812037 BLISTER PACK in 1 CARTON (0113-0812-03) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK7 blister pack2021-09-090000-00-00NoNoCurrent
0113-0812-66001130812661 BOTTLE in 1 CARTON (0113-0812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-06-210000-00-00NoNoCurrent