FDA.reportPublic FDA data

Mucus Relief

Product NDC
81522-203
11-digit product format
815220203
Labeler code
81522
Product ID
81522-203_f212f808-9349-2b65-e053-2995a90a5775
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
2023-01-11
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
Mucus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-203-02Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
81522-203-02Mucus Relief20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-203MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [FSA STORE INC.]2Current NDC, Legacy NDC, 2 package rows20230113_ec6b5d2f-6568-08d8-e053-2995a90a4d4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNec6b5d2f-6568-08d8-e053-2995a90a4d4b2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDec6b5d2f-6568-08d8-e053-2995a90a4d4b2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYec6b5d2f-6568-08d8-e053-2995a90a4d4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81522-203-02815220203021 BLISTER PACK in 1 CARTON (81522-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2023-01-110000-00-00NoNoCurrent