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 81 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer 1.35oz - Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.32676185-14e8-a56d-e063-6294a90adc7b2025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.3267a5ff-03cb-86c9-e063-6394a90a678d2025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.32681df8-0af0-d9c5-e063-6394a90a00f02025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Botanic BlushALCOHOLShenzhen Lantern Scicence Co.,Ltd.32687109-0843-09e9-e063-6394a90a60272025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Golden GroveALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268b7e9-3de4-335b-e063-6394a90adfa02025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Citrus SuedeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268f248-64da-7a22-e063-6294a90a6dd32025-04-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.32692c9c-11bb-d772-e063-6294a90a50d42025-04-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.32695a30-f9dd-11aa-e063-6294a90a78392025-04-10WarningsExact identifier
application number: M003
Walgreens 91% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.21f204f9-a271-0062-e063-6294a90addcc2025-04-10WarningsExact identifier
application number: M003
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
application number: M003
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.322b90e8-be38-7237-e063-6394a90a488f2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c0bdd-4dc5-52e7-e063-6294a90a13802025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact 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