childrens xyzal allergy

Generic: levocetirizine dihydrochloride

Labeler: chattem, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens xyzal allergy
Generic Name levocetirizine dihydrochloride
Labeler chattem, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 2.5 mg/5mL

Manufacturer
Chattem, Inc.

Identifiers & Regulatory

Product NDC 41167-3535
Product ID 41167-3535_bf07d0c3-0342-4fcc-82e4-954ee3076de0
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA209090
Listing Expiration 2027-12-31
Marketing Start 2023-02-01

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 411673535
Hyphenated Format 41167-3535

Supplemental Identifiers

RxCUI
855168 855170
UNII
SOD6A38AGA

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 xyzal allergy (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number NDA209090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (41167-3535-0) / 148 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (41167-3535-1) / 296 mL in 1 BOTTLE
source: ndc

Packages (2)

41167-3535-0 1 BOTTLE in 1 CARTON (41167-3535-0) / 148 mL in 1 BOTTLE 41167-3535-1 1 BOTTLE in 1 CARTON (41167-3535-1) / 296 mL in 1 BOTTLE

Ingredients (1)

levocetirizine dihydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens Xyzal Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bf07d0c3-0342-4fcc-82e4-954ee3076de0", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855168", "855170"], "spl_set_id": ["a33f2704-d350-428b-b467-91f4775ce17f"], "manufacturer_name": ["Chattem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41167-3535-0)  / 148 mL in 1 BOTTLE", "package_ndc": "41167-3535-0", "marketing_start_date": "20230201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (41167-3535-1)  / 296 mL in 1 BOTTLE", "package_ndc": "41167-3535-1", "marketing_start_date": "20230401"}], "brand_name": "Childrens Xyzal Allergy", "product_id": "41167-3535_bf07d0c3-0342-4fcc-82e4-954ee3076de0", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41167-3535", "generic_name": "Levocetirizine dihydrochloride", "labeler_name": "Chattem, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Xyzal Allergy", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "NDA209090", "marketing_category": "NDA", "marketing_start_date": "20230201", "listing_expiration_date": "20271231"}