leader childrens allergy relief

Generic: diphenhydramine hcl

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name leader childrens allergy relief
Generic Name diphenhydramine hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0474
Product ID 70000-0474_8166578a-7f50-40f6-b681-c965f72288ba
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-12-04

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 700000474
Hyphenated Format 70000-0474

Supplemental Identifiers

RxCUI
1049906
UNII
TC2D6JAD40

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 leader childrens allergy relief (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0474-1) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0474-1 1 BOTTLE in 1 CARTON (70000-0474-1) / 118 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

leader childrens allergy relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8166578a-7f50-40f6-b681-c965f72288ba", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["40d697b7-dc59-4d24-8d46-db635e01b9d5"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0474-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0474-1", "marketing_start_date": "20200103"}], "brand_name": "leader childrens allergy relief", "product_id": "70000-0474_8166578a-7f50-40f6-b681-c965f72288ba", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0474", "generic_name": "Diphenhydramine HCl", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader childrens allergy relief", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191204", "listing_expiration_date": "20261231"}