Home NDC 80684-001 P b pure Antibacterial Hand Sanitizer Ocean Breeze Scented
Product NDC 80684-001
11-digit product format 806840001
Labeler code 80684
Product ID 80684-001_089fffdd-2eed-6928-e063-6294a90af1c6
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler FOURSTAR GROUP USA, INC.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-24
Substance ALCOHOL
Active strength .65 mL/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base P b pure Antibacterial Hand Sanitizer Ocean Breeze Scented
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL .65 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 902574 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80684-001-01 P b pure Antibacterial Hand Sanitizer Ocean Breeze Scented 29 mL in 1 BOTTLE GEL 29 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-001 P B PURE ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED (ALCOHOL) GEL [FOURSTAR GROUP USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231027_b17d3da6-a0f8-55d2-e053-2995a90a6ab9.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 80684-001-01 80684000101 29 mL in 1 BOTTLE (80684-001-01) 29 ml 2020-09-24 0000-00-00 No No Current