roycederm cooldefense refreshing shower gel

Generic: tolnaftate 1.0%

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

Drug Facts

Product Profile

Brand Name roycederm cooldefense refreshing shower gel
Generic Name tolnaftate 1.0%
Labeler roycederm llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

tolnaftate 1 g/100mL

Manufacturer
RoyceDerm LLC

Identifiers & Regulatory

Product NDC 85424-007
Product ID 85424-007_3b3216d6-8cc9-ea89-e063-6294a90ab691
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-08-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85424007
Hyphenated Format 85424-007

Supplemental Identifiers

RxCUI
2689792
UNII
06KB629TKV

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 cooldefense refreshing shower gel (source: ndc)
Generic Name tolnaftate 1.0% (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

85424-007-01 2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP

Ingredients (1)

tolnaftate (1 g/100mL)

Linked Drug Pages (1)

RoyceDerm CoolDefense Refreshing Shower Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3b3216d6-8cc9-ea89-e063-6294a90ab691", "openfda": {"unii": ["06KB629TKV"], "rxcui": ["2689792"], "spl_set_id": ["3b3216d6-8cc8-ea89-e063-6294a90ab691"], "manufacturer_name": ["RoyceDerm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PUMP in 1 CARTON (85424-007-01)  / 250 mL in 1 BOTTLE, PUMP", "package_ndc": "85424-007-01", "marketing_start_date": "20250831"}], "brand_name": "RoyceDerm CoolDefense Refreshing Shower Gel", "product_id": "85424-007_3b3216d6-8cc9-ea89-e063-6294a90ab691", "dosage_form": "LIQUID", "product_ndc": "85424-007", "generic_name": "Tolnaftate 1.0%", "labeler_name": "RoyceDerm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RoyceDerm CoolDefense Refreshing Shower Gel", "active_ingredients": [{"name": "TOLNAFTATE", "strength": "1 g/100mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250831", "listing_expiration_date": "20261231"}