topcare calamine

Generic: calamine 8% and zinc oxide 8% lotion

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare calamine
Generic Name calamine 8% and zinc oxide 8% lotion
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-702
Product ID 36800-702_0ccb3ccc-3531-2d08-e063-6394a90ac91a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800702
Hyphenated Format 36800-702

Supplemental Identifiers

RxCUI
617954
UPC
0036800384323
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 topcare calamine (source: ndc)
Generic Name calamine 8% and zinc oxide 8% lotion (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 CONTAINER (36800-702-96)
source: ndc

Packages (1)

36800-702-96 177 mL in 1 CONTAINER (36800-702-96)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

TopCare Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ccb3ccc-3531-2d08-e063-6394a90ac91a", "openfda": {"upc": ["0036800384323"], "unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["8dcf134e-0427-0c43-e053-2995a90a7c26"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 CONTAINER (36800-702-96)", "package_ndc": "36800-702-96", "marketing_start_date": "20190716"}], "brand_name": "TopCare Calamine", "product_id": "36800-702_0ccb3ccc-3531-2d08-e063-6394a90ac91a", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "36800-702", "generic_name": "calamine 8% and zinc oxide 8% lotion", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}