FDA.reportPublic FDA data

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
IngredientStrength
ALCOHOL500 mg/g
LIDOCAINE HYDROCHLORIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
71aeaf86-2b4d-4945-9606-a9db0ab6b726Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5200-12024-02-1361010-5200, Sting Relief
61010-5200-22024-02-1361010-5200, Sting Relief
61010-5200-42024-02-1361010-5200, Sting Relief
61010-5200-52024-02-1361010-5200, Sting Relief
61010-5200-62024-02-1361010-5200, Sting Relief
61010-5200-72024-02-1361010-5200, Sting Relief
61010-5200-12024-01-3061010-5200, Sting Relief
61010-5200-22024-01-3061010-5200, Sting Relief
61010-5200-42024-01-3061010-5200, Sting Relief
61010-5200-52024-01-3061010-5200, Sting Relief
61010-5200-62024-01-3061010-5200, Sting Relief
61010-5200-72024-01-3061010-5200, Sting Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5200-1Antiseptic56 g in 1 BOTTLELIQUID564
61010-5200-2Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-2Antiseptic100 in 1 BOXLIQUID1004
61010-5200-3Antiseptic0.8 g in 1 PACKETLIQUID0.84
61010-5200-4Antiseptic150 in 1 BOXLIQUID1504
61010-5200-5Antiseptic10 in 1 BOXLIQUID104
61010-5200-6Antiseptic20 in 1 BOXLIQUID204
61010-5200-6Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-7Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-7Antiseptic25 in 1 BOXLIQUID254

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90MANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
lidocaine hydrochlorideACTIVE INGREDIENTV13007Z41AANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
alcoholACTIVE MOIETY3K9958V90MANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
lidocaineACTIVE MOIETY98PI200987ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
lidocaine hydrochlorideINACTIVE INGREDIENTV13007Z41AANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5200ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 10 package rows20240214_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 90 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
application number: M003
All Good Rose Geranium Hand SanitizerETHYL ALCOHOLElemental Herbs, Inc.f9b93df2-e28d-840e-e053-6294a90ae48a2024-12-20WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5200-16101052000156 g in 1 BOTTLE (61010-5200-1) 56 g2011-09-300000-00-00NoNoCurrent
61010-5200-261010520002100 PACKET in 1 BOX (61010-5200-2) / 1.8 g in 1 PACKET100 packet2011-09-300000-00-00NoNoCurrent
61010-5200-3610105200030.8 g in 1 PACKET0.8 gHistorical
61010-5200-461010520004150 PACKET in 1 BOX (61010-5200-4) / .8 g in 1 PACKET (61010-5200-3) 150 packet2011-09-300000-00-00NoNoCurrent
61010-5200-56101052000510 PACKET in 1 BOX (61010-5200-5) / .8 g in 1 PACKET (61010-5200-3) 10 packet2011-09-300000-00-00NoNoCurrent
61010-5200-66101052000620 PACKET in 1 BOX (61010-5200-6) / 1.8 g in 1 PACKET20 packet2011-09-300000-00-00NoNoCurrent
61010-5200-76101052000725 PACKET in 1 BOX (61010-5200-7) / 1.8 g in 1 PACKET25 packet2011-09-300000-00-00NoNoCurrent