Home NDC 84269-3501 Antiseptic
Product NDC 84269-3501
11-digit product format 842693501
Labeler code 84269
Product ID 84269-3501_544f5843-189c-a04b-e063-6294a90a9b78
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride, benzocaine
Dosage form SPRAY
Route TOPICAL
Labeler Wildman Business Group
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 50; 1 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Antiseptic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 50 mg/g BENZALKONIUM CHLORIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup 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 1245229 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 84269-3501-1 Antiseptic 60 g in 1 BOTTLE, SPRAY SPRAY 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84269-3501 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [WILDMAN BUSINESS GROUP] 1 Current NDC, 1 package rows 20240901_1fd15b91-6b81-d0bd-e063-6294a90a4d27.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 69 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Hand Sanitizer Cherry Blossom 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2869cb20-9cd4-54f5-e063-6294a90a5fea 2025-09-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Vanilla Sugar 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 28694168-3362-de4f-e063-6394a90a2e35 2025-09-05 Warnings Exact identifier application number: M003 Smart Care Cucumber Melon Hand Sanitizer ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3e0a5382-7b58-fd6e-e063-6394a90abf66 2025-09-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3e09c0aa-0241-0816-e063-6294a90a481e 2025-09-05 Warnings Exact identifier application number: M003 Smart Care Sweet Pea Hand Sanitizer sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3080d8a2-a780-e79b-e063-6294a90ac654 2025-09-05 Warnings Exact identifier application number: M003 Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3081e1b5-66b4-77a8-e063-6394a90a8dd3 2025-09-05 Warnings Exact identifier application number: M003 Smart Care 1oz Hand Sanitizer Island Mango 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 30847dd5-e378-1a35-e063-6294a90a43da 2025-09-05 Warnings Exact identifier application number: M003 Smart Care 1oz Hand Sanitizer Vanilla Heaven 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3084d980-29ca-91ca-e063-6294a90a6c67 2025-09-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3099e6af-8072-d26b-e063-6394a90a39ef 2025-09-05 Warnings Exact identifier application number: M003 Povidone Iodine Prep POVIDONE IODINE Sion Biotext Medical Ltd e05af551-647d-4278-bb7f-86f888ddbb8b 2025-09-04 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. a8eedcfd-3b97-497a-9a34-d59b0dd78439 2025-09-03 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. 40cc6501-3cee-24cc-e054-00144ff88e88 2025-09-03 Warnings Exact identifier application number: M003 5OCT ANTIBACTERL HAND WIPES 5OCT ANTIBACTERL HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa 2025-09-01 Warnings Exact identifier application number: M003 AeroWipe STING RELIEF PAD Aero Healthcare US LLC 3d851c98-c9b9-f084-e063-6294a90acde2 2025-08-29 Warnings Exact identifier application number: M003 wet wipes 01 BENZALKONIUM CHLORIDE Cosmuses Cosmetics (Ningbo) Co., Ltd. 3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e 2025-08-25 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Brazilian Caramel Dreams ALCOHOL Scent Theory Products LLC 3d0d4ccf-ea31-cab2-e063-6294a90a4c69 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Sunset Samba ALCOHOL Scent Theory Products LLC 3d0d7d6b-33a0-5cd1-e063-6394a90ac8f6 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco Creme ALCOHOL Scent Theory Products LLC 3d0d7e73-8a83-9577-e063-6294a90aff6c 2025-08-23 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC fe439c60-5a02-648f-e053-6294a90a1403 2025-08-23 Warnings Exact identifier application number: M003 OP-First Aid Series ALCOHOL PREP PADS STERILE ISOPROPYL ALCOHOL CLOTH Yiwu Ori-Power Medtech Co.,Ltd. 351f4b1e-75c9-abec-e063-6294a90a2875 2025-08-22 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84269-3501-1 84269350101 60 g in 1 BOTTLE, SPRAY 60 g Historical 84269-3501-2 84269350102 60 g in 1 BOTTLE, SPRAY (84269-3501-2) 60 g 2026-03-19 No No Current