children allergy

Generic: fexofenadine hcl

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name children allergy
Generic Name fexofenadine hcl
Labeler h e b
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 30 mg/5mL

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-654
Product ID 37808-654_d7157433-04e6-4dfb-bd7c-8a4d5935df73
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203330
Listing Expiration 2026-12-31
Marketing Start 2023-10-31

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 37808654
Hyphenated Format 37808-654

Supplemental Identifiers

RxCUI
997491
UPC
0041220221820
UNII
2S068B75ZU

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 children allergy (source: ndc)
Generic Name fexofenadine hcl (source: ndc)
Application Number ANDA203330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (37808-654-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

37808-654-04 1 BOTTLE, PLASTIC in 1 BOX (37808-654-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

fexofenadine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

Children Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7157433-04e6-4dfb-bd7c-8a4d5935df73", "openfda": {"upc": ["0041220221820"], "unii": ["2S068B75ZU"], "rxcui": ["997491"], "spl_set_id": ["a26c3515-4a24-4988-b9bb-813420b15630"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (37808-654-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "37808-654-04", "marketing_start_date": "20231031"}], "brand_name": "Children Allergy", "product_id": "37808-654_d7157433-04e6-4dfb-bd7c-8a4d5935df73", "dosage_form": "SUSPENSION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37808-654", "generic_name": "Fexofenadine HCL", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Children Allergy", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA203330", "marketing_category": "ANDA", "marketing_start_date": "20231031", "listing_expiration_date": "20261231"}