childrens allergy relief

Generic: cetirizine hydrochloride

Labeler: fred's, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy relief
Generic Name cetirizine hydrochloride
Labeler fred's, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Fred's, Inc.

Identifiers & Regulatory

Product NDC 55315-354
Product ID 55315-354_17d2db07-4de0-4e02-8e2e-0082c275faab
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090750
Listing Expiration 2026-12-31
Marketing Start 2015-01-31

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55315354
Hyphenated Format 55315-354

Supplemental Identifiers

RxCUI
1014673
UPC
0084579127580
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens allergy relief (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

55315-354-31 1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

CHILDRENS ALLERGY RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17d2db07-4de0-4e02-8e2e-0082c275faab", "openfda": {"upc": ["0084579127580"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["55e799b2-e325-4286-aa9a-b88e99ab1146"], "manufacturer_name": ["Fred's, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55315-354-31)  / 120 mL in 1 BOTTLE", "package_ndc": "55315-354-31", "marketing_start_date": "20150131"}], "brand_name": "CHILDRENS ALLERGY RELIEF", "product_id": "55315-354_17d2db07-4de0-4e02-8e2e-0082c275faab", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55315-354", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Fred's, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHILDRENS ALLERGY RELIEF", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090750", "marketing_category": "ANDA", "marketing_start_date": "20150131", "listing_expiration_date": "20261231"}