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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only When using this product Avoid contact with eyes. In case of contact, rinse thoroughly with water. Stop use and ask a doctor. If irritation or redness develops and lasts Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately.
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 Identifiers# Field, Values table Field Values Unii F5UM2KM3W7 Rxcui 1046593
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
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