barrier cream

Generic: zinc oxide

Labeler: avasol llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name barrier cream
Generic Name zinc oxide
Labeler avasol llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 100 mg/100mL

Manufacturer
Avasol LLC

Identifiers & Regulatory

Product NDC 58518-040
Product ID 58518-040_fbc1e407-09f5-1d83-e053-6294a90aef0f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2022-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58518040
Hyphenated Format 58518-040

Supplemental Identifiers

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 barrier cream (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/100mL
source: ndc
Packaging
  • 59 mL in 1 POUCH (58518-040-02)
  • 28 mL in 1 TUBE (58518-040-03)
source: ndc

Packages (2)

58518-040-02 59 mL in 1 POUCH (58518-040-02) 58518-040-03 28 mL in 1 TUBE (58518-040-03)

Ingredients (1)

zinc oxide (100 mg/100mL)

Linked Drug Pages (1)

Barrier Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "fbc1e407-09f5-1d83-e053-6294a90aef0f", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["bc6a2736-faa6-46d3-af9b-a70f0762e9ce"], "manufacturer_name": ["Avasol LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 POUCH (58518-040-02)", "package_ndc": "58518-040-02", "marketing_start_date": "20220101"}, {"sample": false, "description": "28 mL in 1 TUBE (58518-040-03)", "package_ndc": "58518-040-03", "marketing_start_date": "20220101"}], "brand_name": "Barrier Cream", "product_id": "58518-040_fbc1e407-09f5-1d83-e053-6294a90aef0f", "dosage_form": "CREAM", "product_ndc": "58518-040", "generic_name": "ZINC OXIDE", "labeler_name": "Avasol LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Barrier Cream", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "100 mg/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220101", "listing_expiration_date": "20271231"}