Home NDC 13302-457 QS Plus Instant Hand Sanitizer
Product NDC 13302-457
11-digit product format 133020457
Labeler code 13302
Product ID 13302-457_43e07b93-ddf3-e4be-e063-6294a90a20f1
Type HUMAN OTC DRUG
Nonproprietary name BENZEALKONIUM CHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Romaine Companies
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-02
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13302-457-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13302-457-14 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13302-457-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base QS Plus Instant Hand Sanitizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
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 1020365 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 13302-457-10 QS Plus Instant Hand Sanitizer 1000 mL in 1 CARTRIDGE LIQUID 1000 4 13302-457-14 QS Plus Instant Hand Sanitizer 3785 mL in 1 BOTTLE, PLASTIC LIQUID 3785 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13302-457 QS PLUS INSTANT HAND SANITIZER (BENZEALKONIUM CHLORIDE) LIQUID [ROMAINE COMPANIES] 3 Current NDC, Legacy NDC, 2 package rows 20250112_5e16f52d-3bf3-4897-bd3a-cf4e117583c9.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 22 of 22 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
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 13302-457-10 13302045710 1000 mL in 1 CARTRIDGE (13302-457-10) 1000 ml 2019-07-02 0000-00-00 No No Current 13302-457-12 13302045712 1000 mL in 1 BAG (13302-457-12) 1000 ml 2019-07-02 0000-00-00 No No Current 13302-457-13 13302045713 800 mL in 1 BAG (13302-457-13) 800 ml 2019-07-02 0000-00-00 No No Current 13302-457-14 13302045714 3785 mL in 1 BOTTLE, PLASTIC (13302-457-14) 3785 ml 2022-11-04 0000-00-00 No No Current 13302-457-16 13302045716 236 mL in 1 BOTTLE, PLASTIC (13302-457-16) 236 ml 2019-07-02 0000-00-00 No No Current 13302-457-17 13302045717 532 mL in 1 BOTTLE, PLASTIC (13302-457-17) 532 ml 2019-07-02 0000-00-00 No No Current 13302-457-18 13302045718 50 mL in 1 BOTTLE, PLASTIC (13302-457-18) 50 ml 2019-07-02 0000-00-00 No No Current 13302-457-27 13302045727 800 mL in 1 CARTRIDGE (13302-457-27) 800 ml 2019-07-02 0000-00-00 No No Current