Healthy Accents Childrens Allergy

Product NDC

55316-475

11-digit product format

553160475

Labeler code

55316

Product ID

55316-475_c7dfebf8-2825-4d61-8899-ec1524338032

Type

HUMAN OTC DRUG

Nonproprietary name

Cetirizine HCl

Dosage form

SOLUTION

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA204226

Marketing category

ANDA

Marketing start

2015-12-09

Marketing end

0000-00-00

Substance

CETIRIZINE HYDROCHLORIDE

Active strength

5 mg/5mL

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record