Mucus Relief

Product NDC
53942-203
11-digit product format
539420203
Labeler code
53942
Product ID
53942-203_ea23a104-e734-9a62-e053-2a95a90a9cb2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-10-01
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
53942-203-02Mucus Relief20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202
53942-203-02Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-203MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [DEMOULAS SUPER MARKETS, INC]2Current NDC, Legacy NDC, 2 package rows20221004_e8948cbe-1eca-490d-e053-2995a90a6ba1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe8948cbe-1eca-490d-e053-2995a90a6ba12
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe8948cbe-1eca-490d-e053-2995a90a6ba12
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe8948cbe-1eca-490d-e053-2995a90a6ba12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-203-02539420203021 BLISTER PACK in 1 CARTON (53942-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-10-010000-00-00NoNoCurrent