assured calamine

Generic: calamine 8% and zinc oxide 8%

Labeler: greenbriar international
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name assured calamine
Generic Name calamine 8% and zinc oxide 8%
Labeler greenbriar international
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
Greenbriar International

Identifiers & Regulatory

Product NDC 33992-4130
Product ID 33992-4130_0ccb40f9-0734-b059-e063-6394a90aa03c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2020-01-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 339924130
Hyphenated Format 33992-4130

Supplemental Identifiers

RxCUI
617954
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 assured 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 (33992-4130-6)
source: ndc

Packages (1)

33992-4130-6 177 mL in 1 BOTTLE, PLASTIC (33992-4130-6)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Assured Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ccb40f9-0734-b059-e063-6394a90aa03c", "openfda": {"unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["9d378cc5-9af0-1389-e053-2995a90a0b96"], "manufacturer_name": ["Greenbriar International"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (33992-4130-6)", "package_ndc": "33992-4130-6", "marketing_start_date": "20200127"}], "brand_name": "Assured Calamine", "product_id": "33992-4130_0ccb40f9-0734-b059-e063-6394a90aa03c", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "33992-4130", "generic_name": "Calamine 8% and Zinc Oxide 8%", "labeler_name": "Greenbriar International", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Assured Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200127", "listing_expiration_date": "20261231"}