FDA.reportPublic FDA data

Mucus Relief Maximum Strength 1200 mg

Product NDC
53041-191
11-digit product format
530410191
Labeler code
53041
Product ID
53041-191_2ad8b5c2-9495-4ba0-886b-b5f13484aef1
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA209215
Marketing category
ANDA
Marketing start
2020-06-24
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
Mucus Relief Maximum Strength 1200 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621, 636522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-191-37Mucus Relief Maximum Strength 1200 mg28 in 1 BOTTLETABLET, EXTENDED RELEASE285
53041-191-48Mucus Relief Maximum Strength 1200 mg7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE75
53041-191-48Mucus Relief Maximum Strength 1200 mg4 in 1 CARTONTABLET, EXTENDED RELEASE45
53041-191-58Mucus Relief Maximum Strength 1200 mg7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE75
53041-191-58Mucus Relief Maximum Strength 1200 mg2 in 1 CARTONTABLET, EXTENDED RELEASE25
53041-191-62Mucus Relief Maximum Strength 1200 mg70 in 1 BOTTLETABLET, EXTENDED RELEASE705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-191MUCUS RELIEF 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE MUCUS RELIEF MAXIMUM STRENGTH 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY]5Current NDC, Legacy NDC, 6 package rows20240502_e7742a43-9066-4e28-a90d-f07c0e18f045.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNe7742a43-9066-4e28-a90d-f07c0e18f0455
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe7742a43-9066-4e28-a90d-f07c0e18f0455
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDe7742a43-9066-4e28-a90d-f07c0e18f0455
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe7742a43-9066-4e28-a90d-f07c0e18f0455
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYe7742a43-9066-4e28-a90d-f07c0e18f0455
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe7742a43-9066-4e28-a90d-f07c0e18f0455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-191-375304101913728 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-37) 2024-04-30NoNoHistorical
53041-191-48530410191484 BLISTER PACK in 1 CARTON (53041-191-48) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2020-06-240000-00-00NoNoCurrent
53041-191-58530410191582 BLISTER PACK in 1 CARTON (53041-191-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-06-240000-00-00NoNoCurrent
53041-191-625304101916270 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-62) 2024-04-30NoNoHistorical