Home NDC 61010-5300 Antiseptic
Product NDC 61010-5300
11-digit product format 610105300
Labeler code 61010
Product ID 61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride, benzocaine
Dosage form SPRAY
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-15
Substance BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength 1; 50 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 BENZALKONIUM CHLORIDE 1 mg/g BENZOCAINE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup U3RSY48JW5 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5300-0 Antiseptic 60 g in 1 BOTTLE, SPRAY SPRAY 60 4 61010-5300-2 Antiseptic 90 g in 1 BOTTLE, SPRAY SPRAY 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded benzalkonium chloride ACTIVE INGREDIENT F5UM2KM3W7 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzocaine ACTIVE INGREDIENT U3RSY48JW5 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzalkonium ACTIVE MOIETY 7N6JUD5X6Y ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzocaine ACTIVE MOIETY U3RSY48JW5 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5300 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.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 111 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rite Aid Decolorized Iodine ETHYL ALCOHOL Rite Aid Corporation 5e0d3664-b02a-ba28-e053-2991aa0a8a4c 2023-12-15 Warnings Exact identifier application number: M003 De La Cruz Tincture of Iodine IODINE AND SODIUM IODIDE AND ALCOHOL DLC Laboratories, Inc. 5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b 2023-12-15 Warnings Exact identifier application number: M003 ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 0c73f4f5-2b1d-84ae-e063-6394a90a5d7b 2023-12-14 Warnings Exact identifier application number: M003 TaeTu Aftercare BENZALKONIUM CHLORIDE Taetu LLC dec15a4d-1a33-a78a-e053-2995a90a69fe 2023-12-14 Warnings Exact identifier application number: M003 GNP Idoinde Tincture 2% Mild IODINE AND SODIUM IODIDE AND ALCOHOL Amerisource Bergen 32ad75b8-abd1-4151-a035-b6c9ae5fc888 2023-12-14 Warnings Exact identifier application number: M003 Antibacterial Wet Wipes BENZALKONIUM CHLORIDE HangZhou YangYi Daily Cosmetics Technology Co., Ltd. 85d3914d-dbb8-5036-e053-2a91aa0a7cd4 2023-12-13 Warnings Exact identifier application number: M003 AntiochPharma Rapidgel Hand Sanitizer ALCOHOL Weeks & Leo 0c57a9ea-de66-3ced-e063-6294a90a4b8d 2023-12-12 Warnings Exact identifier application number: M003 antiseptic hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. e9f9b7b6-fed7-10e1-e053-2a95a90a9aa6 2023-12-11 Warnings Exact identifier application number: M003 AntiochPharma Hand Sanitizer ALCOHOL Weeks & Leo a1a0d368-b004-59b8-e053-2995a90ab4b1 2023-12-11 Warnings Exact identifier application number: M003 Septihol Hand Sanitizer ALCOHOL STERIS Corporation 279c5c6f-bf45-499f-a5a2-ddb535382146 2023-12-06 Warnings Exact identifier application number: M003 Zany Antiseptic Gel ALCOHOL Laboratorios Zepol S.A. ee085cb5-0ebf-498c-b622-b2c29d34bb9b 2023-12-01 Warnings Exact identifier application number: M003 Prep Pad Sterile POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd 758abf53-ad8a-62ac-e053-2991aa0a8f0c 2023-11-15 Warnings Exact identifier application number: M003 FIRSTAR Alcohol Prep Pad ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 49a86020-b888-423f-99a5-02fa938105ec 2023-11-15 Warnings Exact identifier application number: M003 CVS Health Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL CVS Health 4678074a-16f1-5480-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M003 Care One 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Ahold U.S.A., Inc. 607b6917-2880-4b1c-83c6-f1297a828ecc 2023-11-10 Warnings Exact identifier application number: M003 Topcare 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Topco Associates LLC dc4b07b6-6476-4e32-901a-da8115d6a197 2023-11-10 Warnings Exact identifier application number: M003 Topcare 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Topco Associates LLC bf9ee7da-69d9-47a2-8748-6b978ca3c298 2023-11-10 Warnings Exact identifier application number: M003 MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 40c7cfc6-ef3b-4759-b9e9-6d7e1319a847 2023-11-09 Warnings Exact identifier application number: M003 BZK Antiseptic Wipe BENZALKONIUM CHLORIDE Changzhou Maokang Medical Products Co., Ltd fe5eb694-4b1b-4c47-95d5-6074155c438a 2023-11-09 Warnings Exact identifier application number: M003 Leader Alcohol 70 Isopropyl Alcohol ISOPROPYL ALCOHOL Cardinal Health 4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d 2023-11-09 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 Marketing end Sample Exclude flag Status 61010-5300-0 61010530000 60 g in 1 BOTTLE, SPRAY (61010-5300-0) 60 g 2012-02-15 0000-00-00 No No Current 61010-5300-2 61010530002 90 g in 1 BOTTLE, SPRAY (61010-5300-2) 90 g 2012-02-15 0000-00-00 No No Current