topcare calaclear

Generic: pramoxine hydrochloride and zinc acetate lotion

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

Drug Facts

Product Profile

Brand Name topcare calaclear
Generic Name pramoxine hydrochloride and zinc acetate lotion
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc acetate 1 mg/mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-267
Product ID 36800-267_0ccb3e8a-3d01-1364-e063-6294a90a70e8
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 36800267
Hyphenated Format 36800-267

Supplemental Identifiers

RxCUI
1234546
UNII
88AYB867L5 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 topcare calaclear (source: ndc)
Generic Name pramoxine hydrochloride and zinc acetate lotion (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 177 mL in 1 CONTAINER (36800-267-96)
source: ndc

Packages (1)

36800-267-96 177 mL in 1 CONTAINER (36800-267-96)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc acetate (1 mg/mL)

Linked Drug Pages (1)

TopCare Calaclear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ccb3e8a-3d01-1364-e063-6294a90a70e8", "openfda": {"unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546"], "spl_set_id": ["8dce8817-b905-4064-e053-2995a90a071e"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 CONTAINER (36800-267-96)", "package_ndc": "36800-267-96", "marketing_start_date": "20190716"}], "brand_name": "TopCare Calaclear", "product_id": "36800-267_0ccb3e8a-3d01-1364-e063-6294a90a70e8", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "36800-267", "generic_name": "pramoxine hydrochloride and zinc acetate lotion", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Calaclear", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC ACETATE", "strength": "1 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}