calamine

Generic: calamine and zinc oxide

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine and zinc oxide
Labeler walgreen company
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-9410
Product ID 0363-9410_29f99f0a-e520-6d9d-e063-6394a90afb57
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03639410
Hyphenated Format 0363-9410

Supplemental Identifiers

RxCUI
617954
UNII
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 calamine (source: ndc)
Generic Name calamine and zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (0363-9410-97)
source: ndc

Packages (1)

0363-9410-97 177 mL in 1 BOTTLE (0363-9410-97)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29f99f0a-e520-6d9d-e063-6394a90afb57", "openfda": {"unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["fed3026b-3473-26fe-e053-6294a90a8aa2"], "manufacturer_name": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (0363-9410-97)", "package_ndc": "0363-9410-97", "marketing_start_date": "20231016"}], "brand_name": "calamine", "product_id": "0363-9410_29f99f0a-e520-6d9d-e063-6394a90afb57", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0363-9410", "generic_name": "Calamine and Zinc oxide", "labeler_name": "WALGREEN COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231016", "listing_expiration_date": "20261231"}