FDA.reportPublic FDA data

Good Sense Mucus ER

Product NDC
0113-4077
11-digit product format
001134077
Labeler code
0113
Product ID
0113-4077_30860399-d9a3-409b-bfac-00597c74b175
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078912
Marketing category
ANDA
Marketing start
2025-04-24
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
0113-4077-01Good Sense Mucus ER4 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL41
0113-4077-01Good Sense Mucus ER7 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL71
0113-4077-74Good Sense Mucus ER2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL21
0113-4077-74Good Sense Mucus ER7 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-4077-74EA - Each0113-40771ae2f37b-5653-4ae7-a168-8219c7b2cd4a12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN30860399-d9a3-409b-bfac-00597c74b1751
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD30860399-d9a3-409b-bfac-00597c74b1751
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY30860399-d9a3-409b-bfac-00597c74b1751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-4077-01001134077014 BLISTER PACK in 1 CARTON (0113-4077-01) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2025-06-20NoNoHistorical
0113-4077-74001134077742 BLISTER PACK in 1 CARTON (0113-4077-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-04-24NoNoHistorical