Mucus Relief
Drug Facts
Approved
Approval ID
ddc18f31-acb2-4305-929a-f4746efd4224
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 24, 2025
Manufacturers
FDA
Family Dollar (FAMILY WELLNESS)
DUNS: 024472631
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guaifenesin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55319-733
Application NumberANDA207342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2025
FDA Product Classification
INGREDIENTS (10)
GUAIFENESINActive
Quantity: 1200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT