burn gel 01

Generic: melaleuca alternifolia (tea tree) leaf oil

Labeler: cosmuses cosmetics (ningbo) co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name burn gel 01
Generic Name melaleuca alternifolia (tea tree) leaf oil
Labeler cosmuses cosmetics (ningbo) co., ltd.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

melaleuca alternifolia (tea tree) leaf oil 1 g/100g

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.

Identifiers & Regulatory

Product NDC 82953-045
Product ID 82953-045_3227b643-a99e-6716-e063-6294a90a73b7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2025-04-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82953045
Hyphenated Format 82953-045

Supplemental Identifiers

UNII
VIF565UC2G

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 burn gel 01 (source: ndc)
Generic Name melaleuca alternifolia (tea tree) leaf oil (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • .85 g in 1 POUCH (82953-045-01)
source: ndc

Packages (1)

82953-045-01 .85 g in 1 POUCH (82953-045-01)

Ingredients (1)

melaleuca alternifolia (tea tree) leaf oil (1 g/100g)

Linked Drug Pages (1)

burn gel 01 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3227b643-a99e-6716-e063-6294a90a73b7", "openfda": {"unii": ["VIF565UC2G"], "spl_set_id": ["3227bdc9-9323-68eb-e063-6294a90a29d2"], "manufacturer_name": ["Cosmuses Cosmetics (Ningbo) Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".85 g in 1 POUCH (82953-045-01)", "package_ndc": "82953-045-01", "marketing_start_date": "20250406"}], "brand_name": "burn gel 01", "product_id": "82953-045_3227b643-a99e-6716-e063-6294a90a73b7", "dosage_form": "GEL", "product_ndc": "82953-045", "generic_name": "melaleuca alternifolia (tea tree) leaf oil", "labeler_name": "Cosmuses Cosmetics (Ningbo) Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "burn gel", "brand_name_suffix": "01", "active_ingredients": [{"name": "MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL", "strength": "1 g/100g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250406", "listing_expiration_date": "20261231"}