calamine phenolated topical suspension

Generic: calamine and zinc oxide and phenol

Labeler: pharma nobis, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine phenolated topical suspension
Generic Name calamine and zinc oxide and phenol
Labeler pharma nobis, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

phenol 10 mg/mL, zinc oxide 160 mg/mL

Manufacturer
Pharma Nobis, LLC

Identifiers & Regulatory

Product NDC 82645-921
Product ID 82645-921_0d6ccb8f-d9bf-28e6-e063-6294a90a8a87
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 82645921
Hyphenated Format 82645-921

Supplemental Identifiers

RxCUI
991369
UPC
0010939147332 0087701400674
UNII
339NCG44TV 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 phenolated topical suspension (source: ndc)
Generic Name calamine and zinc oxide and phenol (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (82645-921-96)
source: ndc

Packages (1)

82645-921-96 177 mL in 1 BOTTLE, PLASTIC (82645-921-96)

Ingredients (2)

phenol (10 mg/mL) zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Calamine Phenolated Topical Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0d6ccb8f-d9bf-28e6-e063-6294a90a8a87", "openfda": {"upc": ["0010939147332", "0087701400674"], "unii": ["339NCG44TV", "SOI2LOH54Z"], "rxcui": ["991369"], "spl_set_id": ["e42fbdcc-3291-7761-e053-2995a90a7172"], "manufacturer_name": ["Pharma Nobis, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (82645-921-96)", "package_ndc": "82645-921-96", "marketing_start_date": "20171116"}], "brand_name": "Calamine Phenolated Topical Suspension", "product_id": "82645-921_0d6ccb8f-d9bf-28e6-e063-6294a90a8a87", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "82645-921", "generic_name": "Calamine and Zinc Oxide and Phenol", "labeler_name": "Pharma Nobis, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine Phenolated Topical Suspension", "active_ingredients": [{"name": "PHENOL", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080101", "listing_expiration_date": "20261231"}