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 86 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Cucumber Melon ETHYL ALCOHOL Rejoice International 021fa2a0-d2ea-4699-a3d8-3c0af18c5aa3 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Lavender Chamomile ETHYL ALCOHOL Rejoice International 6e611e87-1835-49f8-aa52-b724bd251527 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Sweet Pea Blossom ETHYL ALCOHOL Rejoice International 1a5408f2-910c-4c6a-b6b3-c1304dd1cdf0 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Warm Vanilla ETHYL ALCOHOL Rejoice International 46e7b4fa-3722-4487-9325-f8552ea92acf 2025-02-12 Warnings Exact identifier application number: M003 Instant Hand Sanitizer 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 5b209df6-d896-170c-e053-2a91aa0a52a8 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e62eb50-ebb8-361e-e053-2991aa0aba6f 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e6585a3-61e1-30ec-e053-2a91aa0a6039 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Spider Man 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dedab76-3f5a-febf-e063-6394a90a6993 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e65856c-0e14-1ab6-e053-2991aa0a3f3e 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Barbie 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfd2ffd-a85a-f63e-e063-6294a90a6a5e 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Crayola 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfd4acb-451b-12d3-e063-6294a90a4873 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Hot Wheels 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfdd225-24f4-6d57-e063-6394a90a8a24 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Cucumber Melon Hand Sanitizer 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfe0ac7-99d5-aac3-e063-6294a90a31b3 2025-02-12 Warnings Exact identifier application number: M003 Isopropyl alcohol 70 percent ISOPROPYL ALCOHOL Good Sense (Geiss, Destin & Dunn, Inc.) ac66be77-d358-44ea-8904-88186a7c2bbb 2025-02-07 Warnings Exact identifier application number: M003 Rubbing Alcohol 70 Percent Isopropyl ISOPROPYL ALCOHOL Harris Teeter, LLC 4196dd97-9041-4712-8196-02237a3b0cb2 2025-02-07 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Harris Teeter, LLC 1b044f47-45e1-40a3-81b0-2717ed425f16 2025-02-07 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e042f5b-3f0c-1830-e054-00144ff88e88 2025-02-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e04fa70-c25d-4499-e054-00144ff8d46c 2025-02-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e05cceb-b8f3-48f7-e054-00144ff88e88 2025-02-06 Warnings Exact identifier application number: M003 Hand Sanitizer 1.8 oz Antiseptic ETHYL ALCOHOL REJOICE INTERNATIONAL CORP. a0313f20-11dc-6c7d-e053-2a95a90a60f1 2025-02-06 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