sudocrem skin protectant

Generic: zinc oxide

Labeler: leda innovations usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sudocrem skin protectant
Generic Name zinc oxide
Labeler leda innovations usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 152.9 mg/g

Manufacturer
LEDA INNOVATIONS USA, INC.

Identifiers & Regulatory

Product NDC 84589-002
Product ID 84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2024-08-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84589002
Hyphenated Format 84589-002

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 sudocrem skin protectant (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 152.9 mg/g
source: ndc
Packaging
  • 1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR
  • 125 g in 1 JAR (84589-002-12)
  • 250 g in 1 JAR (84589-002-25)
  • 400 g in 1 JAR (84589-002-40)
  • 60 g in 1 JAR (84589-002-60)
source: ndc

Packages (5)

84589-002-10 1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR 84589-002-12 125 g in 1 JAR (84589-002-12) 84589-002-25 250 g in 1 JAR (84589-002-25) 84589-002-40 400 g in 1 JAR (84589-002-40) 84589-002-60 60 g in 1 JAR (84589-002-60)

Ingredients (1)

zinc oxide (152.9 mg/g)

Linked Drug Pages (1)

SUDOCREM SKIN PROTECTANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "20d2cf0b-d236-fd78-e063-6394a90a8d03", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["20d2cf0b-d237-fd78-e063-6394a90a8d03"], "manufacturer_name": ["LEDA INNOVATIONS USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 JAR in 1 BLISTER PACK (84589-002-10)  / 10 g in 1 JAR", "package_ndc": "84589-002-10", "marketing_start_date": "20240806"}, {"sample": false, "description": "125 g in 1 JAR (84589-002-12)", "package_ndc": "84589-002-12", "marketing_start_date": "20240806"}, {"sample": false, "description": "250 g in 1 JAR (84589-002-25)", "package_ndc": "84589-002-25", "marketing_start_date": "20240806"}, {"sample": false, "description": "400 g in 1 JAR (84589-002-40)", "package_ndc": "84589-002-40", "marketing_start_date": "20240806"}, {"sample": false, "description": "60 g in 1 JAR (84589-002-60)", "package_ndc": "84589-002-60", "marketing_start_date": "20240806"}], "brand_name": "SUDOCREM SKIN PROTECTANT", "product_id": "84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03", "dosage_form": "CREAM", "product_ndc": "84589-002", "generic_name": "ZINC OXIDE", "labeler_name": "LEDA INNOVATIONS USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SUDOCREM SKIN PROTECTANT", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "152.9 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240806", "listing_expiration_date": "20261231"}