roycederm tea tree therapeutic

Generic: salicylic acid 3%

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

Drug Facts

Product Profile

Brand Name roycederm tea tree therapeutic
Generic Name salicylic acid 3%
Labeler roycederm llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

salicylic acid 3 mg/100mL

Manufacturer
RoyceDerm LLC

Identifiers & Regulatory

Product NDC 85424-012
Product ID 85424-012_46542754-2257-a23c-e063-6394a90a7795
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M032
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85424012
Hyphenated Format 85424-012

Supplemental Identifiers

UNII
O414PZ4LPZ

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 roycederm tea tree therapeutic (source: ndc)
Generic Name salicylic acid 3% (source: ndc)
Application Number M032 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/100mL
source: ndc
Packaging
  • 350 mL in 1 CARTON (85424-012-01)
source: ndc

Packages (1)

85424-012-01 350 mL in 1 CARTON (85424-012-01)

Ingredients (1)

salicylic acid (3 mg/100mL)

Linked Drug Pages (1)

RoyceDerm Tea Tree Therapeutic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "46542754-2257-a23c-e063-6394a90a7795", "openfda": {"unii": ["O414PZ4LPZ"], "spl_set_id": ["46542754-2256-a23c-e063-6394a90a7795"], "manufacturer_name": ["RoyceDerm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "350 mL in 1 CARTON (85424-012-01)", "package_ndc": "85424-012-01", "marketing_start_date": "20251215"}], "brand_name": "RoyceDerm Tea Tree Therapeutic", "product_id": "85424-012_46542754-2257-a23c-e063-6394a90a7795", "dosage_form": "GEL", "product_ndc": "85424-012", "generic_name": "Salicylic Acid 3%", "labeler_name": "RoyceDerm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RoyceDerm Tea Tree Therapeutic", "active_ingredients": [{"name": "SALICYLIC ACID", "strength": "3 mg/100mL"}], "application_number": "M032", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}