FDA.reportPublic FDA data

NUMSTAT Antiseptic and Pain Relieving Prep Pad

Product NDC
65282-1815
Requested package NDC
65282-1815-2
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 95 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPS RANCH HAND ANTIBACTERIAL FOAMINGCHLOROXYLENOLArcher Manufacturing, Inc.d8187090-8423-062e-e053-2a95a90aad182024-12-05WarningsExact identifier
application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d335bf6d-dc75-bd80-e053-2a95a90abb562024-12-05WarningsExact identifier
application number: M003
OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d4c65a93-832a-6a8b-e053-2a95a90a77b82024-12-05WarningsExact identifier
application number: M003
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
application number: M003
antiseptic towelette 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
application number: M003
BobBarker antibacterial wrapped bodyBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa52024-12-04WarningsExact identifier
application number: M003
Walgreens 70% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreen Co.21f125a0-73e8-34a9-e063-6294a90a83962024-12-04WarningsExact identifier
application number: M003
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
application number: M003
Watermelon Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f0f9885-2ad5-09de-e063-6394a90ad0d72024-12-03WarningsExact identifier
application number: M003
Foster and Thrive Povidone-IodinePOVIDONE IODINEStrategic Sourcing Services, LLC28621f29-ce45-c6dc-e063-6294a90aa5f72024-12-03WarningsExact identifier
application number: M003
Sanitizing Hand Mist UnscentedETHYL ALCOHOLALO New York LLCe194daee-2197-4718-e053-2a95a90a48902024-12-03WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Global291eaa18-81f8-6907-e054-00144ff88e882024-12-03WarningsExact identifier
application number: M003
Aquabain Antibacterial Passion BerrysBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.aee5d7c2-93b3-f55e-e053-2995a90af72e2024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial Fresh and RelaxBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d3086-7902-2837-e053-2995a90a39df2024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial GrapefruitBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f49-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial Red FruitsBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f4d-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand OatmealBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e1c5f6-195c-16d6-e063-6394a90abb862024-12-02WarningsExact identifier
application number: M003
Aquabain Instant Hand SanitizerETHYL ALCOHOL 70%Industria La Popular, S.A.b2e4d58d-adff-3cb2-e053-2995a90a392e2024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2289d-60f4-260c-e063-6394a90a96f62024-12-02WarningsExact identifier
application number: M003
Jabonito Kids Green Apple LiquidBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.021bc525-3ebe-efc2-e063-6394a90a3fe32024-12-02WarningsExact 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
65282-1815-265282181502100 PACKET in 1 CARTON (65282-1815-2) / 1 g in 1 PACKET100 packet2023-01-01NoNoCurrent