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 45 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biopure Antibacterial Hand Wipe Berry Strawberry BENZALKONIUM CHLORIDE Quest USA Corp 47d6574c-0d4c-392e-e063-6394a90a590f 2026-01-07 Warnings Exact identifier application number: M003 Biopure Antibacterial Hand Wipe Vallina Dream BENZALKONIUM CHLORIDE Quest USA Corp 47d7090d-036b-870b-e063-6394a90a80c3 2026-01-07 Warnings Exact identifier application number: M003 99 Plus Hand Sanitizer BENZEALKONIUM CHLORIDE Momar Incorporated f972a8f1-c928-4e4b-a8dd-a2fb77052d21 2026-01-06 Warnings Exact identifier application number: M003 Benzocaine BENZOCAINE Dynarex Corporation 6161e94c-7849-466e-8da3-a6f1b085bdf9 2026-01-06 Warnings Exact identifier application number: M003 Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent BENZALKONIUM CHLORIDE Quest USA Corp 47c105a8-7c76-9cde-e063-6294a90a9284 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER VANILLA ETHYL ALCOHOL Rejoice International Corp. 47c3c187-da54-7c3b-e063-6294a90af3ce 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER CHAMPAGNE BLASH ETHYL ALCOHOL Rejoice International Corp. 47c5e9af-4ea8-fb39-e063-6394a90aa5ab 2026-01-06 Warnings Exact identifier application number: M003 Antiseptic Cleaning wipe ANTISEPTIC CLEANING WIPE SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d01ae-d99e-bce3-e063-6294a90a1a2d 2026-01-05 Warnings Exact identifier application number: M003 Povidone-lodine prep pad POVIDONE-LODINE PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 201545b8-0697-5601-e063-6394a90a12f4 2026-01-05 Warnings Exact identifier application number: M003 Sting Relief prep Pad STING RELIEF PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 202c7b77-1a48-52a5-e063-6394a90a2eb2 2026-01-05 Warnings Exact identifier application number: M003 Skin Cleaning Care Wipes SKIN CLEANING CARE WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d7a95-65fe-ca65-e063-6294a90acc6e 2026-01-05 Warnings Exact identifier application number: M003 ANTISEPTIC CLEANSING WIPE(0.9% NACL) ANTISEPTIC CLEANSING WIPE(0.9% NACL) SHENZHEN BENLIJU BIO-TECH CO.,LTD 33e1c026-8a35-a47a-e063-6294a90a2406 2026-01-05 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes HAND SANITIZING WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 37487da6-4e0e-6625-e063-6394a90a0af1 2026-01-05 Warnings Exact identifier application number: M003 Hand wipes HAND WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 39f3acca-7275-88ca-e063-6394a90ad1a2 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Vanilla Heaven ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a0781b-9b25-f04b-e063-6294a90ae7e5 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a16397-dff3-7d79-e063-6394a90a040f 2026-01-05 Warnings Exact identifier application number: M003 IDOSWAB B ISOPROPYL ALCOHOL IDO PHARM 16d19630-b67a-f3e1-e063-6394a90a7429 2026-01-05 Warnings Exact identifier application number: M003 Sure Comfort Alcohol Prep Pads ISOPROPYL ALCOHOL IDO PHARM 27def94b-d3a6-18b7-e063-6394a90a22a6 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Lemon Lime ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeaae9-740d-a28a-e063-6294a90a6460 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Calming Lavender ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeeef9-0eed-e7d0-e063-6394a90a6d31 2026-01-05 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