FDA.reportPublic FDA data

NUMSTAT Antiseptic and Pain Relieving Prep Pad

Product NDC
65282-1815
11-digit product format
652821815
Labeler code
65282
Product ID
65282-1815_0ceeef4e-90fe-d542-e063-6394a90abc8d
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol, menthol, and benzocaine prep pad
Dosage form
SWAB
Route
TOPICAL
Labeler
Spectra Medical Devices, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
BENZOCAINE; ISOPROPYL ALCOHOL; MENTHOL
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
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE15 g/100g
ISOPROPYL ALCOHOL71 g/100g
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
ND2M416302Internal UNII lookup
L7T10EIP3AInternal 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
07d20040-9dd9-0aba-e063-6294a90ab7cfAvailable 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
65282-1815-1NUMSTAT Antiseptic and Pain Relieving Prep Pad30 in 1 CARTONSWAB302
65282-1815-1NUMSTAT Antiseptic and Pain Relieving Prep Pad1 g in 1 PACKETSWAB12
65282-1815-2NUMSTAT Antiseptic and Pain Relieving Prep Pad100 in 1 CARTONSWAB1002
65282-1815-2NUMSTAT Antiseptic and Pain Relieving Prep Pad1 g in 1 PACKETSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65282-1815NUMSTAT ANTISEPTIC AND PAIN RELIEVING PREP PAD (ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD) SWAB [SPECTRA MEDICAL DEVICES, LLC]2Current NDC, 4 package rows20231221_07d20040-9dd9-0aba-e063-6294a90ab7cf.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 97 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadPSN07d20040-9dd9-0aba-e063-6294a90ab7cf2
2667826NUMSTAT 71 % / 15 % / 1 % Medicated PadPSN07d20040-9dd9-0aba-e063-6294a90ab7cf2
2667826benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated Pad [Numstat]SBD07d20040-9dd9-0aba-e063-6294a90ab7cf2
2667820benzocaine 150 MG/ML / isopropyl alcohol 0.71 ML/ML / menthol 10 MG/ML Medicated PadSCD07d20040-9dd9-0aba-e063-6294a90ab7cf2
2667820benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % Medicated PadSY07d20040-9dd9-0aba-e063-6294a90ab7cf2
2667826Numstat (benzocaine 15 % / isopropyl alcohol 71 % / menthol 1 % ) Medicated PadSY07d20040-9dd9-0aba-e063-6294a90ab7cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65282-1815-16528218150130 PACKET in 1 CARTON (65282-1815-1) / 1 g in 1 PACKET30 packet2023-01-01NoNoCurrent
65282-1815-265282181502100 PACKET in 1 CARTON (65282-1815-2) / 1 g in 1 PACKET100 packet2023-01-01NoNoCurrent