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childrens allergy relief

Rite Aid Corporation Children’s Allergy Relief Drug Facts

Approved
Approval ID

539336e6-7979-47ed-b1ea-fd46ef547aee

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 5, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

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 Code11822-0620
Application NumberANDA075728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 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

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childrens allergy relief - FDA Drug Approval Details