leader calamine plus

Generic: zinc oxide lotion

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

Drug Facts

Product Profile

Brand Name leader calamine plus
Generic Name zinc oxide lotion
Labeler cardinal health, 110 dba leader
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Cardinal Health, 110 dba Leader

Identifiers & Regulatory

Product NDC 70000-0400
Product ID 70000-0400_0d1994b2-3c1b-6322-e063-6394a90a1b6c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000400
Hyphenated Format 70000-0400

Supplemental Identifiers

RxCUI
1234532
UPC
0096295135145
UNII
88AYB867L5 SOI2LOH54Z

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 calamine plus (source: ndc)
Generic Name zinc oxide lotion (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 CONTAINER (70000-0400-1)
source: ndc

Packages (1)

70000-0400-1 177 mL in 1 CONTAINER (70000-0400-1)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Leader Calamine Plus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0d1994b2-3c1b-6322-e063-6394a90a1b6c", "openfda": {"upc": ["0096295135145"], "unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532"], "spl_set_id": ["81f29789-f794-1e64-e053-2a91aa0ac85e"], "manufacturer_name": ["Cardinal Health, 110 dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 CONTAINER (70000-0400-1)", "package_ndc": "70000-0400-1", "marketing_start_date": "20190215"}], "brand_name": "Leader Calamine Plus", "product_id": "70000-0400_0d1994b2-3c1b-6322-e063-6394a90a1b6c", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "70000-0400", "generic_name": "zinc oxide lotion", "labeler_name": "Cardinal Health, 110 dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Calamine Plus", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}