Home NDC 61010-5200 Antiseptic
Product NDC 61010-5200
11-digit product format 610105200
Labeler code 61010
Product ID 61010-5200_10d353b1-16fc-5ddd-e063-6294a90a8fd7
Type HUMAN OTC DRUG
Nonproprietary name alcohol, lidocaine hydrochloride
Dosage form LIQUID
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-09-30
Substance ALCOHOL; LIDOCAINE HYDROCHLORIDE
Active strength 500; 20 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 ALCOHOL 500 mg/g LIDOCAINE HYDROCHLORIDE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5200-1 2024-02-13 61010-5200, Sting Relief 61010-5200-2 2024-02-13 61010-5200, Sting Relief 61010-5200-4 2024-02-13 61010-5200, Sting Relief 61010-5200-5 2024-02-13 61010-5200, Sting Relief 61010-5200-6 2024-02-13 61010-5200, Sting Relief 61010-5200-7 2024-02-13 61010-5200, Sting Relief 61010-5200-1 2024-01-30 61010-5200, Sting Relief 61010-5200-2 2024-01-30 61010-5200, Sting Relief 61010-5200-4 2024-01-30 61010-5200, Sting Relief 61010-5200-5 2024-01-30 61010-5200, Sting Relief 61010-5200-6 2024-01-30 61010-5200, Sting Relief 61010-5200-7 2024-01-30 61010-5200, Sting Relief
DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded alcohol ACTIVE INGREDIENT 3K9958V90M ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 lidocaine hydrochloride ACTIVE INGREDIENT V13007Z41A ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 alcohol ACTIVE MOIETY 3K9958V90M ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 lidocaine ACTIVE MOIETY 98PI200987 ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 lidocaine hydrochloride INACTIVE INGREDIENT V13007Z41A ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5200 ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 4 Current NDC, Legacy NDC, 10 package rows 20240214_71aeaf86-2b4d-4945-9606-a9db0ab6b726.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61010-5200-1 61010520001 56 g in 1 BOTTLE (61010-5200-1) 56 g 2011-09-30 0000-00-00 No No Current 61010-5200-2 61010520002 100 PACKET in 1 BOX (61010-5200-2) / 1.8 g in 1 PACKET 100 packet 2011-09-30 0000-00-00 No No Current 61010-5200-3 61010520003 0.8 g in 1 PACKET 0.8 g Historical 61010-5200-4 61010520004 150 PACKET in 1 BOX (61010-5200-4) / .8 g in 1 PACKET (61010-5200-3) 150 packet 2011-09-30 0000-00-00 No No Current 61010-5200-5 61010520005 10 PACKET in 1 BOX (61010-5200-5) / .8 g in 1 PACKET (61010-5200-3) 10 packet 2011-09-30 0000-00-00 No No Current 61010-5200-6 61010520006 20 PACKET in 1 BOX (61010-5200-6) / 1.8 g in 1 PACKET 20 packet 2011-09-30 0000-00-00 No No Current 61010-5200-7 61010520007 25 PACKET in 1 BOX (61010-5200-7) / 1.8 g in 1 PACKET 25 packet 2011-09-30 0000-00-00 No No Current