calamine clear

Generic: pramoxine hydrochloride and zinc acetate lotion

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

Drug Facts

Product Profile

Brand Name calamine clear
Generic Name pramoxine hydrochloride and zinc acetate lotion
Labeler cardinal health, 110 dba leader
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Cardinal Health, 110 dba Leader

Identifiers & Regulatory

Product NDC 70000-0397
Product ID 70000-0397_185584d0-0662-431c-e063-6394a90a4827
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000397
Hyphenated Format 70000-0397

Supplemental Identifiers

RxCUI
1234546
UPC
0096295135091
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 calamine clear (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 BOTTLE, PLASTIC (70000-0397-1)
source: ndc

Packages (1)

70000-0397-1 177 mL in 1 BOTTLE, PLASTIC (70000-0397-1)

Ingredients (2)

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

Linked Drug Pages (1)

Calamine Clear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "185584d0-0662-431c-e063-6394a90a4827", "openfda": {"upc": ["0096295135091"], "unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546"], "spl_set_id": ["7f733c0a-82b2-d3b0-e053-2991aa0a6b0f"], "manufacturer_name": ["Cardinal Health, 110 dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (70000-0397-1)", "package_ndc": "70000-0397-1", "marketing_start_date": "20190115"}], "brand_name": "Calamine Clear", "product_id": "70000-0397_185584d0-0662-431c-e063-6394a90a4827", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "70000-0397", "generic_name": "Pramoxine Hydrochloride and Zinc Acetate Lotion", "labeler_name": "Cardinal Health, 110 dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine Clear", "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": "20190115", "listing_expiration_date": "20261231"}