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Equaline Childrens Allergy Relief

SuperValu Inc. Children’s Allergy Relief Drug Facts

Approved
Approval ID

11e889d8-833c-4043-a1af-7ffaf3fda61d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

United Natural Foods, Inc. dba UNFI

DUNS: 943556183

Products 1

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

loratadine

PRODUCT DETAILS

NDC Product Code41163-633
Application NumberANDA075728
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic Nameloratadine

INGREDIENTS (11)

LORATADINEActive
Quantity: 5 mg in 5 mL
Code: 7AJO3BO7QN
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
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
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Equaline Childrens Allergy Relief - FDA Approval | MedPath