calamine

Generic: calamine 8% and zinc oxide 8%

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

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine 8% and zinc oxide 8%
Labeler pharma nobis, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
Pharma Nobis, LLC

Identifiers & Regulatory

Product NDC 82645-900
Product ID 82645-900_0d1cd55e-cd93-6e7e-e063-6294a90ae7a5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 1998-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82645900
Hyphenated Format 82645-900

Supplemental Identifiers

RxCUI
617954
UPC
0072036987235 0087701400926 0036800384323 0681131176002 0010939148339 0084579118762 0635515945074 0015127009515 0045591041964
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 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 (82645-900-96)
source: ndc

Packages (1)

82645-900-96 177 mL in 1 BOTTLE, PLASTIC (82645-900-96)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0d1cd55e-cd93-6e7e-e063-6294a90ae7a5", "openfda": {"upc": ["0072036987235", "0087701400926", "0036800384323", "0681131176002", "0010939148339", "0084579118762", "0635515945074", "0015127009515", "0045591041964"], "unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["e42f0bd6-3ad3-7e07-e053-2995a90a564a"], "manufacturer_name": ["Pharma Nobis, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (82645-900-96)", "package_ndc": "82645-900-96", "marketing_start_date": "20171113"}], "brand_name": "Calamine", "product_id": "82645-900_0d1cd55e-cd93-6e7e-e063-6294a90ae7a5", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "82645-900", "generic_name": "Calamine 8% and Zinc Oxide 8%", "labeler_name": "Pharma Nobis, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}