Leader All Day Sinus and Cold D
Cardinal Health All Day Sinus & Cold-D Drug Facts
Approved
Approval ID
83f7cfbb-ab84-4594-ae7a-4a657385c8a7
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 25, 2025
Manufacturers
FDA
Cardinal Health 110, LLC. dba Leader
DUNS: 063997360
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen sodium, Pseudoephedrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70000-0605
Application NumberANDA076518
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen sodium, Pseudoephedrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (12)
NAPROXEN SODIUMActive
Quantity: 220 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT