wellstar amenity

Generic: benzalkonium chloride and sodium monofluorophosphate

Labeler: asp global, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name wellstar amenity
Generic Name benzalkonium chloride and sodium monofluorophosphate
Labeler asp global, llc
Dosage Form KIT
Manufacturer
ASP Global, LLc

Identifiers & Regulatory

Product NDC 59448-800
Product ID 59448-800_961c53ef-0590-4aa8-8cef-667615bd0c4b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59448800
Hyphenated Format 59448-800

Supplemental Identifiers

RxCUI
545626 581660

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 wellstar amenity (source: ndc)
Generic Name benzalkonium chloride and sodium monofluorophosphate (source: ndc)
Application Number M003 (source: ndc)

Resolved Composition

Strengths
  • 62 %
  • 0.76 %
  • 0.15 %
source: label
Packaging
  • 20 BAG in 1 BOX (59448-800-00) / 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-008-01)
source: ndc

Packages (1)

59448-800-00 20 BAG in 1 BOX (59448-800-00) / 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-008-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Wellstar Amenity ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "961c53ef-0590-4aa8-8cef-667615bd0c4b", "openfda": {"rxcui": ["545626", "581660"], "spl_set_id": ["ced9dd96-7922-43d7-906f-32afaad733ec"], "manufacturer_name": ["ASP Global, LLc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 BOX (59448-800-00)  / 1 KIT in 1 BAG *  59 mL in 1 TUBE *  65 mL in 1 BOTTLE, PLASTIC *  4.25 g in 1 TUBE *  59 mL in 1 TUBE *  14 g in 1 BOTTLE, WITH APPLICATOR *  59 mL in 1 TUBE *  10 g in 1 TUBE (42555-060-45)  *  53 mL in 1 BOTTLE, PLASTIC (59448-008-01)", "package_ndc": "59448-800-00", "marketing_start_date": "20211001"}], "brand_name": "Wellstar Amenity", "product_id": "59448-800_961c53ef-0590-4aa8-8cef-667615bd0c4b", "dosage_form": "KIT", "product_ndc": "59448-800", "generic_name": "Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE", "labeler_name": "ASP Global, LLc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Wellstar Amenity", "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}