FDA.reportPublic FDA data

Curist Mucus Relief

Product NDC
72559-013
11-digit product format
725590013
Labeler code
72559
Product ID
72559-013_4c255f1c-c660-024b-e063-6294a90a0a6e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Little Pharma, Inc.
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-07-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Curist Mucus Relief
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

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
72559-013-11Curist Mucus ReliefMaximum Strength6 in 1 CARTONTABLET, EXTENDED RELEASE69
72559-013-11Curist Mucus ReliefMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE149
72559-013-28Curist Mucus ReliefMaximum Strength150 in 1 BOTTLETABLET, EXTENDED RELEASE1509
72559-013-41Curist Mucus ReliefMaximum Strength150 in 1 BOTTLETABLET, EXTENDED RELEASE1509
72559-013-41Curist Mucus ReliefMaximum Strength2 in 1 PACKAGE, COMBINATIONTABLET, EXTENDED RELEASE29
72559-013-64Curist Mucus ReliefMaximum Strength84 in 1 BOTTLETABLET, EXTENDED RELEASE849

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-013CURIST MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [LITTLE PHARMA, INC.]7Current NDC, Legacy NDC, 6 package rows20241116_c7d1136c-a712-2ac5-e053-2995a90a4dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNc7d1136c-a712-2ac5-e053-2995a90a4dd49
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDc7d1136c-a712-2ac5-e053-2995a90a4dd49
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYc7d1136c-a712-2ac5-e053-2995a90a4dd49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-013-11725590013116 BLISTER PACK in 1 CARTON (72559-013-11) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2021-07-230000-00-00NoNoCurrent
72559-013-2872559001328150 TABLET, EXTENDED RELEASE in 1 BOTTLE (72559-013-28) 2022-04-060000-00-00NoNoCurrent
72559-013-41725590013412 BOTTLE in 1 PACKAGE, COMBINATION (72559-013-41) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE2 bottle2021-07-23NoNoHistorical
72559-013-647255900136484 TABLET, EXTENDED RELEASE in 1 BOTTLE (72559-013-64) 2025-11-15NoNoHistorical