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 93 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Univ of Vermont Medical Center Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7841cfa9-e94e-4c3d-b5fb-676924017845 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Mothers Vaginal ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7f1a85fd-086b-4fc7-abac-863dd3ea505a 2024-12-17 Warnings Exact identifier application number: M003 Mary Kay Satin Hands Shea Hand Sanitizer ALCOHOL Mary Kay Inc. b6c2b979-2940-1569-e053-2995a90a532c 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive Decolorized Iodine ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981529a-2bd0-3e9e-e063-6294a90a7236 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981cb97-17de-ebda-e063-6394a90ad281 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital H.E.A.R.T. Strings Tote ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc f8369a27-1995-4fdd-a282-35c344c11d83 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 877ce875-c5b0-4d9b-8f00-682914e3bc0e 2024-12-17 Warnings Exact identifier application number: M003 Wellstar Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc ced9dd96-7922-43d7-906f-32afaad733ec 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital C-Section Mothers ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 9df6d0e9-631c-4619-9d96-d2c5a32a590e 2024-12-17 Warnings Exact identifier application number: M003 Memorial Sloan Kettering Cancer Center Amenity Kit SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc cab0bef1-f486-4eac-a61b-6030467d8650 2024-12-17 Warnings Exact identifier application number: M003 Sarasota Memorial Amenity ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc f5dda019-fcfd-4e99-89cc-e79e76b402e7 2024-12-17 Warnings Exact identifier application number: M003 Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 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