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
NDC Product Code70000-0605
Application NumberANDA076518
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 25, 2025
Generic NameNaproxen sodium, Pseudoephedrine HCl
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