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 113 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 1c7f9a00-6600-4b0d-af11-fa776b22e678 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 1c9f2c8b-6ed6-4e54-a151-5be4acb290e4 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 878bfaa7-d553-40db-8311-19010930abd9 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd c1273e40-5c09-435b-adf3-e352fdd01e9e 2023-10-23 Warnings Exact identifier application number: M003 POVIDONE IODINE SCRUB SWABSTICK 3s POVIDONE-IODINE Jianerkang Medical Co., Ltd 65783da9-acca-41c7-860b-1de108edc583 2023-10-23 Warnings Exact identifier application number: M003 Obstetrical Towelette BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 8db4eb14-85b6-4c8e-9623-39a43b3827a1 2023-10-23 Warnings Exact identifier application number: M003 POVIDONE IODINE PREP PAD Sterile POVIDONE-IODINE Jianerkang Medical Co., Ltd ac3aa401-a124-4eb7-9598-119be0f24ddd 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd c13af96e-f76a-4577-8d57-811ccc652738 2023-10-23 Warnings Exact identifier application number: M003 Povidone-Iodine Prep Pad POVIDONE-IODINE Cardinal Health 200, Inc. 06c8a6f6-2fc8-4292-a3b5-6311a918a521 2023-10-23 Warnings Exact identifier application number: M003 Antiseptic BZK Towelette BENZALKONIUM CHLORIDE Cardinal Health 200, Inc. 8dd79ffe-f742-438c-9814-612f900ad6a9 2023-10-23 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd f231a572-a99d-4146-afa3-e73ea1cee027 2023-10-22 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd 42778607-6170-4a5e-94d0-5e6cd064eec6 2023-10-22 Warnings Exact identifier application number: M003 Alcohol ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 76048b01-28f3-4e43-9da9-974b2b511a10 2023-10-22 Warnings Exact identifier application number: M003 GENUINE FIRST AID Antiseptic Hand Sanitizer ETHYL ALCOHOL Nantong Health & Beyond Hygienic Products Inc. d25f02f1-268c-44d8-9a55-c6efcbe8eed1 2023-10-19 Warnings Exact identifier application number: M003 Brompton and Langley Moisturizing Hand Sanitizer Lavnder Vanilla ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 90bd3436-a8bc-4c19-a300-d59236a8de27 2023-10-19 Warnings Exact identifier application number: M003 Up and Up 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Target Corporation becc8fe3-eaf5-4429-b462-a87dd09c4db8 2023-10-17 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 766ad4df-2100-4f26-bd8b-5c5a0918698e 2023-10-13 Warnings Exact identifier application number: M003 GoodSense Alcohol Swabs ISOPROPYL ALCOHOL Geiss, Destin and Dunn 968bab9f-5b74-270b-e053-2995a90a0df4 2023-10-13 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 5854f241-6cfc-4e5a-ba72-92dd0703f728 2023-10-13 Warnings Exact identifier application number: M003 DawnMist Alcohol Hand Sanitizer ALCOHOL Dukal LLC a2df96a9-8514-6839-e053-2a95a90a9417 2023-10-13 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