childrens allergy relief

Generic: cetirizine hydrochloride

Labeler: c.d.m.a., inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy relief
Generic Name cetirizine hydrochloride
Labeler c.d.m.a., inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
C.D.M.A., Inc.

Identifiers & Regulatory

Product NDC 63868-865
Product ID 63868-865_434f1b5b-1e26-406a-a5e2-df310b74e993
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090750
Listing Expiration 2026-12-31
Marketing Start 2014-11-20

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 63868865
Hyphenated Format 63868-865

Supplemental Identifiers

RxCUI
1014673
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 (63868-865-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "434f1b5b-1e26-406a-a5e2-df310b74e993", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["b4feed95-86ca-411c-99b5-773e485e752f"], "manufacturer_name": ["C.D.M.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63868-865-04)  / 120 mL in 1 BOTTLE", "package_ndc": "63868-865-04", "marketing_start_date": "20141120"}], "brand_name": "CHILDRENS ALLERGY RELIEF", "product_id": "63868-865_434f1b5b-1e26-406a-a5e2-df310b74e993", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63868-865", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "C.D.M.A., 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": "20141120", "listing_expiration_date": "20261231"}