FDA.reportPublic FDA data

Good Sense Mucus ER

Product NDC
0113-3650
11-digit product format
001133650
Labeler code
0113
Product ID
0113-3650_a3d91c63-d72e-4ddd-8092-e0108b7937a8
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-03-20
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
0113-3650-00Good Sense Mucus ER14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL145
0113-3650-00Good Sense Mucus ER1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15
0113-3650-01Good Sense Mucus ER14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL145
0113-3650-01Good Sense Mucus ER2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL25
0113-3650-10Good Sense Mucus ER1 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL15
0113-3650-10Good Sense Mucus ER7 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL75
0113-3650-74Good Sense Mucus ER1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15
0113-3650-74Good Sense Mucus ER14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-3650-00EA - Each0113-365080e8e5a4-a0ba-4abb-bbdc-bbf0f6ff8d2512024-02-14
0113-3650-01EA - Each0113-3650fd4c497b-4c42-4766-b5cd-d09aeeb5ddb312024-02-14
0113-3650-74EA - Each0113-3650b97005ed-2af1-4419-9640-5ba0f467c5cb12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-3650GOOD SENSE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 8 package rows20240229_49de9c3b-9840-4fc2-988f-4361de6aa3c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN49de9c3b-9840-4fc2-988f-4361de6aa3c15
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD49de9c3b-9840-4fc2-988f-4361de6aa3c15
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY49de9c3b-9840-4fc2-988f-4361de6aa3c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-3650-00001133650001 BLISTER PACK in 1 CARTON (0113-3650-00) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-03-310000-00-00NoNoCurrent
0113-3650-01001133650012 BLISTER PACK in 1 CARTON (0113-3650-01) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-09-090000-00-00NoNoCurrent
0113-3650-10001133650107 BLISTER PACK in 1 CARTON (0113-3650-10) > 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK7 blister pack2022-05-050000-00-00NoNoCurrent
0113-3650-74001133650741 BLISTER PACK in 1 CARTON (0113-3650-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-03-200000-00-00NoNoCurrent