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 103 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb77267-73ad-efd2-e063-6294a90a43f72024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb7d6ca-ef7e-5225-e063-6294a90aa6922024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb4316d-c8c6-3fa2-e063-6394a90a23d22024-07-07WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsExact identifier
application number: M003
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
application number: M003
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
application number: M003
Walgreens 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEWalgreen Company03c497cc-c8b1-43b7-86ba-f9f9fc7432bf2024-06-18WarningsExact identifier
application number: M003
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
application number: M003
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
application number: M003
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWildman Business Group1f95b277-e40c-4a17-e063-6294a90a11272024-06-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
application number: M003
MyMedic HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.197fc623-2fb9-184c-e063-6394a90a41042024-05-28WarningsExact 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