leader anti itch

Generic: diphenhydramine hydrochloride, zinc acetate

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

Drug Facts

Product Profile

Brand Name leader anti itch
Generic Name diphenhydramine hydrochloride, zinc acetate
Labeler cardinal health 110, llc. dba leader
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

diphenhydramine hydrochloride 2 g/100g, zinc acetate .1 g/100g

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0388
Product ID 70000-0388_62cd1143-2372-499e-a76f-1a562170eaec
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2018-12-13

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000388
Hyphenated Format 70000-0388

Supplemental Identifiers

RxCUI
1087026
UNII
TC2D6JAD40 FM5526K07A

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 anti itch (source: ndc)
Generic Name diphenhydramine hydrochloride, zinc acetate (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
  • .1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (70000-0388-1) / 28 g in 1 TUBE
source: ndc

Packages (1)

70000-0388-1 1 TUBE in 1 CARTON (70000-0388-1) / 28 g in 1 TUBE

Ingredients (2)

diphenhydramine hydrochloride (2 g/100g) zinc acetate (.1 g/100g)

Linked Drug Pages (1)

leader anti itch ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "62cd1143-2372-499e-a76f-1a562170eaec", "openfda": {"unii": ["TC2D6JAD40", "FM5526K07A"], "rxcui": ["1087026"], "spl_set_id": ["e1aab35b-80d9-4515-afb7-8c662bc5d028"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70000-0388-1)  / 28 g in 1 TUBE", "package_ndc": "70000-0388-1", "marketing_start_date": "20181213"}], "brand_name": "leader anti itch", "product_id": "70000-0388_62cd1143-2372-499e-a76f-1a562170eaec", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0388", "generic_name": "Diphenhydramine Hydrochloride, Zinc Acetate", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader anti itch", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "2 g/100g"}, {"name": "ZINC ACETATE", "strength": ".1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181213", "listing_expiration_date": "20261231"}