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FDA Approval

Mucus Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Family Dollar (FAMILY WELLNESS)
DUNS: 024472631
Effective Date
February 24, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Guaifenesin(1200 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Mucus Relief

Product Details

NDC Product Code
55319-733
Application Number
ANDA207342
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 24, 2025
Code: 495W7451VQClass: ACTIBQuantity: 1200 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CARBOMER 934Inactive
Code: Z135WT9208Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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