astonea skin protectant

Generic: zinc oxide

Labeler: astonea labs private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name astonea skin protectant
Generic Name zinc oxide
Labeler astonea labs private limited
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

zinc oxide 18 mg/g

Manufacturer
ASTONEA LABS PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 77338-050
Product ID 77338-050_1bbb3c29-f7ab-8b08-e063-6294a90a0129
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-11-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77338050
Hyphenated Format 77338-050

Supplemental Identifiers

RxCUI
1044412
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 astonea skin protectant (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/g
source: ndc
Packaging
  • 113 g in 1 TUBE (77338-050-04)
source: ndc

Packages (1)

77338-050-04 113 g in 1 TUBE (77338-050-04)

Ingredients (1)

zinc oxide (18 mg/g)

Linked Drug Pages (1)

Astonea Skin Protectant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1bbb3c29-f7ab-8b08-e063-6294a90a0129", "openfda": {"unii": ["SOI2LOH54Z"], "rxcui": ["1044412"], "spl_set_id": ["e3c7a515-3e77-da85-e053-2995a90a3ee1"], "manufacturer_name": ["ASTONEA LABS PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 TUBE (77338-050-04)", "package_ndc": "77338-050-04", "marketing_start_date": "20220817"}], "brand_name": "Astonea Skin Protectant", "product_id": "77338-050_1bbb3c29-f7ab-8b08-e063-6294a90a0129", "dosage_form": "OINTMENT", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "77338-050", "generic_name": "ZINC OXIDE", "labeler_name": "ASTONEA LABS PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Astonea Skin Protectant", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "18 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191121", "listing_expiration_date": "20261231"}