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 82 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Beautifier Life Hand Sanitizer Mist Ocean ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 31628598-f7b8-111b-e063-6394a90a3de2 2025-03-28 Warnings Exact identifier application number: M003 Beautifier Life Hand Sanitizer Mist Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 31633195-d964-278b-e063-6294a90ad42d 2025-03-28 Warnings Exact identifier application number: M003 Beautifier Life Hand Sanitizer Mist Cucumber ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 31642cc2-c3f6-891d-e063-6294a90a2858 2025-03-28 Warnings Exact identifier application number: M003 Meijer BENZALKONIUM CHLORIDE Meijer 1e69a1b6-1b2b-8db7-e063-6294a90a78e9 2025-03-28 Warnings Exact identifier application number: M003 Berberex Wound Gel BENZETHONIUM CHLORIDE, ALLANTOIN Cosco International, Inc. 5dd97e65-bfb3-468e-a2b1-e56d30da99df 2025-03-28 Warnings Exact identifier application number: M003 ANTIBACTERIAL BANDAGES BENZALKONIUM CHLORIDE Guangdong Comfort Medical Products Co., Ltd. da241df2-6153-05e4-e053-2a95a90a0984 2025-03-26 Warnings Exact identifier application number: M003 Caring Mill Hand Advanced Sanitizer ETHYL ALCOHOL 70% Veridian Healthcare 312e0fde-8b5b-1296-e063-6294a90a4f26 2025-03-25 Warnings Exact identifier application number: M003 HAND SANITIZING WIPES HAND SANITIZING WIPES IMAGINE AMAZON LLC 30a373d6-59cd-fc74-e063-6394a90a9a9a 2025-03-24 Warnings Exact identifier application number: M003 Klean-Them Hand Sanitizing Towels BENZALKONIUM CHLORIDE Rite-Kem, Inc. 30dedeee-aadd-6436-e063-6394a90a0cde 2025-03-21 Warnings Exact identifier application number: M003 Saniiswab ISOPROPYL ALCOHOL POLLEY MED LLC 303b1ad5-a104-3479-e063-6294a90abcde 2025-03-20 Warnings Exact identifier application number: M003 XTRA Squeeze Antibacterial Hand Juicy Orange BENZALKONIUM CHLORIDE MY IMPORTS USA LLC 304ab556-36d8-5fba-e063-6394a90a234a 2025-03-19 Warnings Exact identifier application number: M003 XTRA Squeeze Antibacterial Hand Juicy Orange BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 2f03b094-c470-d0f4-e063-6394a90a47fc 2025-03-19 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 30997964-e81e-2159-e063-6294a90ad5dc 2025-03-18 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 309abafa-0118-dd48-e063-6294a90a6e9f 2025-03-18 Warnings Exact identifier application number: M003 Smart Care Strawberry Hand Sanitizer strawberry 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3086faf2-e6e3-a7da-e063-6394a90ace54 2025-03-17 Warnings Exact identifier application number: M003 AEROCLEANSE Instant Hand Sanitizer INSTANT HAND SANITIZER Aero Healthcare 45aad3a4-dc7e-4b51-e054-00144ff88e88 2025-03-12 Warnings Exact identifier application number: M003 Signature Care Instant Hand Sanitizizer Wipes ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. 0f6a30de-4100-4673-ab9e-256bb137919b 2025-03-11 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2fa8bf7a-8efc-923d-e063-6394a90a6bbb 2025-03-06 Warnings Exact identifier application number: M003 Jianerkang One Fluid Ounce Hydrogen Peroxide HYDROGEN PEROXIDE Jianerkang Medical Co., Ltd 0cd2cefc-89db-49f9-b187-150c21e7f671 2025-03-06 Warnings Exact identifier application number: M003 XTRA BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 27df3fce-3958-d4ea-e063-6394a90a1785 2025-03-06 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