Mucus Relief

Product NDC
81522-204
11-digit product format
815220204
Labeler code
81522
Product ID
81522-204_faca6208-912f-d434-e053-6394a90ad95a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
FSA STORE INC.
Application
ANDA213420
Marketing category
ANDA
Marketing start
2023-05-02
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-204-02Mucus Relief2 in 1 PACKAGETABLET, EXTENDED RELEASE22
81522-204-02Mucus Relief14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-204MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [FSA STORE INC.]2Current NDC, 2 package rows20230504_f524479a-2c15-50d9-e053-2995a90a805e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNf524479a-2c15-50d9-e053-2995a90a805e2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDf524479a-2c15-50d9-e053-2995a90a805e2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf524479a-2c15-50d9-e053-2995a90a805e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81522-204-02815220204022 BLISTER PACK in 1 PACKAGE (81522-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2023-05-02NoNoHistorical