FDA.reportPublic FDA data

good sense mucus er

Product NDC
0113-2023
11-digit product format
001132023
Labeler code
0113
Product ID
0113-2023_e4f2d30b-3b0f-47e2-bbe1-266297d5de41
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
2020-07-04
Substance
GUAIFENESIN
Active strength
600 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
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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
0113-2023-58good sense mucus er40 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL403
0113-2023-58good sense mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
0113-2023-60good sense mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
0113-2023-60good sense mucus er20 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-2023-58EA - Each0113-2023da17e939-5569-4a7c-85e5-13ec7435944512025-09-12
0113-2023-60EA - Each0113-2023db504b76-520e-44b1-8ece-c0a9aee4c2be12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-2023GOOD SENSE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 4 package rows20250302_def40c3f-29de-4efc-b1d3-4cb89183aaec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN608b00c5-a2c7-4514-9b46-02954d6675d63
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNdef40c3f-29de-4efc-b1d3-4cb89183aaec3
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD608b00c5-a2c7-4514-9b46-02954d6675d63
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDdef40c3f-29de-4efc-b1d3-4cb89183aaec3
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY608b00c5-a2c7-4514-9b46-02954d6675d63
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYdef40c3f-29de-4efc-b1d3-4cb89183aaec3
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN4fb57f87-f761-b52e-e063-6294a90ae4ee1
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD4fb57f87-f761-b52e-e063-6294a90ae4ee1
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4fb57f87-f761-b52e-e063-6294a90ae4ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-2023-58001132023581 BOTTLE in 1 CARTON (0113-2023-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-07-19NoNoCurrent
0113-2023-60001132023601 BOTTLE in 1 CARTON (0113-2023-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-07-040000-00-00NoNoCurrent