health care calamine

Generic: calamine 8% and zinc oxide 8%

Labeler: great lakes wholesale, marketing and sales inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name health care calamine
Generic Name calamine 8% and zinc oxide 8%
Labeler great lakes wholesale, marketing and sales inc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
Great Lakes Wholesale, Marketing and Sales Inc

Identifiers & Regulatory

Product NDC 64092-413
Product ID 64092-413_0cf4d771-f6b1-ec8c-e063-6394a90a3551
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2008-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64092413
Hyphenated Format 64092-413

Supplemental Identifiers

RxCUI
617954
UPC
0092215710003
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 health care calamine (source: ndc)
Generic Name calamine 8% and zinc oxide 8% (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, PLASTIC (64092-413-96)
source: ndc

Packages (1)

64092-413-96 177 mL in 1 BOTTLE, PLASTIC (64092-413-96)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Health Care Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0cf4d771-f6b1-ec8c-e063-6394a90a3551", "openfda": {"upc": ["0092215710003"], "unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["5d8f02fb-0794-8ec2-e053-2991aa0aac63"], "manufacturer_name": ["Great Lakes Wholesale, Marketing and Sales Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (64092-413-96)", "package_ndc": "64092-413-96", "marketing_start_date": "20171027"}], "brand_name": "Health Care Calamine", "product_id": "64092-413_0cf4d771-f6b1-ec8c-e063-6394a90a3551", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "64092-413", "generic_name": "Calamine 8% and Zinc Oxide 8%", "labeler_name": "Great Lakes Wholesale, Marketing and Sales Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Health Care Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080101", "listing_expiration_date": "20261231"}