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
BENZOCAINE; ISOPROPYL ALCOHOL; MENTHOL, UNSPECIFIED FORM
Active strength
15; 71; 1 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

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
BENZOCAINE15 g/100g
ISOPROPYL ALCOHOL71 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, ND2M416302, L7T10EIP3A
Rxcui2667820, 2667826

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

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 packet2026-04-15NoNoHistorical