dg health childrens allergy
Dolgencorp LLC. Children’s Allergy Drug Facts
Approved
Approval ID
14acf572-e1f0-40f5-82cf-357cb2f3a051
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Dolgencorp, LLC
DUNS: 068331990
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55910-611
Application NumberANDA075728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (11)
LORATADINEActive
Quantity: 5 mg in 5 mL
Code: 7AJO3BO7QN
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT