gel antiseptico dermowipe
Generic: gel antiseptico a base de alcohol etilico
Labeler: key qumica s.a. de c.v.Drug Facts
Product Profile
Brand Name
gel antiseptico dermowipe
Generic Name
gel antiseptico a base de alcohol etilico
Labeler
key qumica s.a. de c.v.
Dosage Form
GEL
Routes
Active Ingredients
alcohol 70 mL/70mL
Manufacturer
Identifiers & Regulatory
Product NDC
58345-103
Product ID
58345-103_2b26aa61-8365-58d9-e063-6294a90ae76b
Product Type
HUMAN OTC DRUG
Marketing Category
OTC MONOGRAPH DRUG
Application Number
505G(a)(3)
Listing Expiration
2026-12-31
Marketing Start
2024-04-05
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
58345103
Hyphenated Format
58345-103
Supplemental Identifiers
UPC
UNII
Packaging Origin
Original Packager
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
gel antiseptico dermowipe (source: ndc)
Generic Name
gel antiseptico a base de alcohol etilico (source: ndc)
Application Number
505G(a)(3) (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 70 mL/70mL
Packaging
- 12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMP
- 6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMP
- 6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAG
- 3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLE
- 4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLE
- 20000 mL in 1 BOTTLE (58345-103-06)
- 3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMP
- 2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMP
Packages (8)
58345-103-01
12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMP
58345-103-02
6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMP
58345-103-03
6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAG
58345-103-04
3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLE
58345-103-05
4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLE
58345-103-06
20000 mL in 1 BOTTLE (58345-103-06)
58345-103-07
3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMP
58345-103-08
2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMP
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "2b26aa61-8365-58d9-e063-6294a90ae76b", "openfda": {"upc": ["7503030886277"], "unii": ["3K9958V90M"], "spl_set_id": ["15620afc-d6ae-0f34-e063-6294a90a8ad2"], "manufacturer_name": ["Key Qumica S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMP", "package_ndc": "58345-103-01", "marketing_start_date": "20240405"}, {"sample": false, "description": "6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMP", "package_ndc": "58345-103-02", "marketing_start_date": "20240405"}, {"sample": false, "description": "6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAG", "package_ndc": "58345-103-03", "marketing_start_date": "20240405"}, {"sample": false, "description": "3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLE", "package_ndc": "58345-103-04", "marketing_start_date": "20240405"}, {"sample": false, "description": "4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLE", "package_ndc": "58345-103-05", "marketing_start_date": "20240405"}, {"sample": false, "description": "20000 mL in 1 BOTTLE (58345-103-06)", "package_ndc": "58345-103-06", "marketing_start_date": "20240405"}, {"sample": false, "description": "3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMP", "package_ndc": "58345-103-07", "marketing_start_date": "20240405"}, {"sample": false, "description": "2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMP", "package_ndc": "58345-103-08", "marketing_start_date": "20240405"}], "brand_name": "Gel Antiseptico Dermowipe", "product_id": "58345-103_2b26aa61-8365-58d9-e063-6294a90ae76b", "dosage_form": "GEL", "product_ndc": "58345-103", "generic_name": "Gel antiseptico a base de alcohol etilico", "labeler_name": "Key Qumica S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gel Antiseptico Dermowipe", "active_ingredients": [{"name": "ALCOHOL", "strength": "70 mL/70mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240405", "listing_expiration_date": "20261231"}