Home NDC 72476-004 Careone Amber
Product NDC 72476-004
11-digit product format 724760004
Labeler code 72476
Product ID 72476-004_50eb1e0e-2183-ec8d-e063-6294a90a34f5
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOAP
Route TOPICAL
Labeler Retail Business Services, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-01
Substance BENZALKONIUM CHLORIDE
Active strength 130 mg/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Careone Amber
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 130 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-004-02 Careone Amber 222 mL in 1 BOTTLE, PLASTIC SOAP 222 5 72476-004-03 Careone Amber 333 mL in 1 BOTTLE, PLASTIC SOAP 333 5 72476-004-04 Careone Amber 1660 mL in 1 BOTTLE, PLASTIC SOAP 1660 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-004 CAREONE AMBER (BENZALKONIUM CHLORIDE) SOAP [RETAIL BUSINESS SERVICES, LLC] 4 Current NDC, Legacy NDC, 3 package rows 20241022_cb8fdf26-8372-70d8-e053-2995a90a840a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72476-004-02 72476000402 222 mL in 1 BOTTLE, PLASTIC (72476-004-02) 222 ml 2021-09-01 0000-00-00 No No Current 72476-004-03 72476000403 333 mL in 1 BOTTLE, PLASTIC (72476-004-03) 333 ml 2021-09-01 0000-00-00 No No Current 72476-004-04 72476000404 1660 mL in 1 BOTTLE, PLASTIC (72476-004-04) 1660 ml 2021-09-01 0000-00-00 No No Current