FDA.reportPublic FDA data

Numstat Antiseptic and Pain-Relieving Prep Pad

Product NDC
61010-8203
11-digit product format
610108203
Labeler code
61010
Product ID
61010-8203_4c9c20f2-bc18-857b-e063-6394a90a5d5c
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic and Pain-Relieving Prep Pad
Dosage form
SWAB
Route
TOPICAL
Labeler
Safetec of America Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-15
Substance
MENTHOL, UNSPECIFIED FORM; ISOPROPYL ALCOHOL; BENZOCAINE
Active strength
1; 71; 15 g/100g; g/100g; g/100g
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
Numstat Antiseptic and Pain-Relieving Prep Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM1 g/100g
ISOPROPYL ALCOHOL71 g/100g
BENZOCAINE15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
ND2M416302Internal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2667820Internal RxNorm lookup
2667826Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c9c20f2-bc17-857b-e063-6394a90a5d5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8203-1Numstat Antiseptic and Pain-Relieving Prep Pad1 g in 1 PACKETSWAB11
61010-8203-2Numstat Antiseptic and Pain-Relieving Prep Pad50 in 1 CARTONSWAB501

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 11 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humco Gentian Violet 2%GENTIAN VIOLET 2%Humco Holding Group, Inc.a07f61e5-0215-419a-a68a-1d814417c35f2026-07-09WarningsExact identifier
application number: M003
GNP Gentian Violet 1%GENTIAN VIOLET 1%Amerrisource Bergen5d07274f-e848-6c60-e053-2991aa0a40d82026-07-09WarningsExact identifier
application number: M003
Drs pharmacy triple antibiotic Pain plus itch plus ScarBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLC16273878-2f58-0d26-e063-6394a90a47d22026-07-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
application number: M003
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
application number: M003
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerETHYL ALCOHOLEverywhereAire LLCb6af3009-78c2-2312-e053-2995a90af90a2026-07-06WarningsExact identifier
application number: M003
Hand Sanitizer gelALCOHOLEverywhereAire LLCd2a6c866-3f1e-20f1-e053-2995a90a26cc2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab3ab67-cb27-6c2b-e053-2a95a90ace122026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands SandalwoodETHANOL HAND SANITIZEREverywhereAire LLC18612a10-8667-b0ef-e063-6394a90a208e2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsETHANOL HAND SANITIZEREverywhereAire LLCb86824c2-4fae-d597-e053-2995a90ad1da2026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands Lemon Olive Oil Hand SanitizerETHANOL HAND SANITIZEREverywhereAire LLC42f8c2fb-a4e6-9416-e063-6294a90af9d52026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL BASEDEverywhereAire LLceab52ae1-f588-b08b-e053-2995a90a96b22026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab19649-21fc-2fa4-e053-2995a90a90f92026-07-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadPSN4c9c20f2-bc17-857b-e063-6394a90a5d5c1
2667826NUMSTAT 71 % / 15 % / 1 % Medicated PadPSN4c9c20f2-bc17-857b-e063-6394a90a5d5c1
2667826benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated Pad [Numstat]SBD4c9c20f2-bc17-857b-e063-6394a90a5d5c1
2667820benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated PadSCD4c9c20f2-bc17-857b-e063-6394a90a5d5c1
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadSY4c9c20f2-bc17-857b-e063-6394a90a5d5c1
2667826Numstat (benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % ) Medicated PadSY4c9c20f2-bc17-857b-e063-6394a90a5d5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61010-8203-1610108203011 g in 1 PACKET1 gHistorical
61010-8203-26101082030250 PACKET in 1 CARTON (61010-8203-2) / 1 g in 1 PACKET (61010-8203-1) 50 packet2026-04-15NoNoCurrent