FDA Product

childrens allergy relief

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

childrens allergy relief

FDA Product Code

11822-0620

Regulatory Information

NDC Product Code

11822-0620

Application Number

ANDA075728

Marketing Category

C73584

Effective Date

May 5, 2025

Territorial Authority

USA

FDA Title

Rite Aid Corporation Children’s Allergy Relief Drug Facts

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

3

Company Information

ManufacturerRite Aid Corporation

DUNS Number

014578892

Active Ingredients

Quantity: 5 mg in 5 mL

Code: 7AJO3BO7QN

Class Code: ACTIB

Inactive Ingredients

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

MALTITOL

Code: D65DG142WK

Class Code: IACT

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Code: 3980JIH2SW

Class Code: IACT

PHOSPHORIC ACID

Code: E4GA8884NN

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

Active Moieties

LORATADINE

Code: 7AJO3BO7QN

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