FDA.reportPublic FDA data

Dukal Sterile Alcohol Prep Pad

Product NDC
65517-0002
Requested package NDC
65517-0002-2
11-digit product format
655170002
Labeler code
65517
Product ID
65517-0002_3377f917-0508-a40c-e063-6394a90ac2ff
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
SWAB
Route
TOPICAL
Labeler
Dukal LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dukal Sterile Alcohol Prep Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00b2c444-8601-4d8f-b6bb-91b864fd9041Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL24
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL24
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.8 mL0.7 mL in 1mL12
65517-0002-1Dukal Sterile Alcohol Prep Pad0.4 mL in 1 POUCHSWAB0.48
65517-0002-3Dukal Sterile Alcohol Prep Pad0.4 mL in 1 POUCHSWAB0.48
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL7
65517-0002-2Dukal Sterile Alcohol Prep Pad1 mL in 1 POUCHSWAB12
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1
65517-0002-1Simlandi0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1
65517-0002-1Adalimumab-ryvk0.4 mL in 1 POUCHSWAB0.4 mL0.7 mL in 1mL1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0002SIMLANDI (ADALIMUMAB-RYVK) KIT [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC20250313_12f609c9-2088-bb05-e063-6394a90a9ecc.zip
65517-0002DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL LLC]8Current NDC, Legacy NDC, 2 package rows20250426_00b2c444-8601-4d8f-b6bb-91b864fd9041.zip
65517-0002ADALIMUMAB-RYVK KIT [QUALLENT PHARMACEUTICALS HEALTH LLC]6Current NDC, Legacy NDC20250326_dce1590f-9e47-4c4d-9437-cfb18b779a75.zip
65517-0002DUKAL STERILE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DUKAL CORPORATION]2Current NDC, Legacy NDC, 1 package rows20190301_54586d75-a0a1-46aa-9cc9-631094320bff.zip
65517-0002ADALIMUMAB-RYVK KIT [TEVA PHARMACEUTICALS USA, INC.]1Current NDC, Legacy NDC20250523_2d19a877-1f5a-4731-800a-dddadc424080.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 43 of 114 · 2,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003
ProCure Antiseptic Wound CleanserBENZETHONIUM CHLORIDE 0.13%Twin Med LLC47e63ead-fdcc-15e9-e063-6394a90af8fa2026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.57ac1673-0652-433b-8b79-962d14e5b3172026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHenry Schein Inc.eeaf255e-497b-4672-bebc-4d3fcba904c72026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.fefaf5ff-e5f4-40d9-a415-a54fb5592ae12026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENavajo Manufacturing Company Inc.0125929d-fabe-4e35-a3a9-a81c42211bed2026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.85d2d57d-6d0b-406a-8880-a697a8c3c6822026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHenry Schein Inc.d97671f0-b182-4dab-87d2-cf9919509da52026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENDC, Inc.23f7a9dc-5a6b-4f17-bf76-3864c48815252026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2688819adalimumab-ryvk 20 MG in 0.2 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688826adalimumab-ryvk 40 MG in 0.4 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2706644adalimumab-ryvk 80 MG in 0.8 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688828adalimumab-ryvk 80 MG in 0.8 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Medicated PadPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688823Simlandi 20 MG in 0.2 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2677787Simlandi 40 MG in 0.4 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688827Simlandi 40 MG in 0.4 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2706645Simlandi 80 MG in 0.8 ML Auto-InjectorPSN12f609c9-2088-bb05-e063-6394a90a9ecc24
2688829Simlandi 80 MG in 0.8 ML Prefilled SyringePSN12f609c9-2088-bb05-e063-6394a90a9ecc24
26888230.2 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26777870.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888270.4 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066450.8 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888290.8 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe [Simlandi]SBD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888190.2 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888260.4 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066440.8 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
26888280.8 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD12f609c9-2088-bb05-e063-6394a90a9ecc24
27066450.8 ML Simlandi 100 MG/ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688819adalimumab-ryvk 20 MG per 0.2 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688826adalimumab-ryvk 40 MG per 0.4 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2706644adalimumab-ryvk 80 MG per 0.8 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688828adalimumab-ryvk 80 MG per 0.8 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Medicated PadSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Topical ClothSY12f609c9-2088-bb05-e063-6394a90a9ecc24
797544isopropyl alcohol 70 % Topical SwabSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688823Simlandi 20 MG per 0.2 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2677787Simlandi 40 MG per 0.4 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688827Simlandi 40 MG per 0.4 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2706645Simlandi 80 MG per 0.8 ML Auto-InjectorSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2688829Simlandi 80 MG per 0.8 ML Prefilled SyringeSY12f609c9-2088-bb05-e063-6394a90a9ecc24
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
2688826adalimumab-ryvk 40 MG in 0.4 ML Prefilled SyringePSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Medicated PadPSNdce1590f-9e47-4c4d-9437-cfb18b779a7512
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
26888260.4 ML adalimumab-ryvk 100 MG/ML Prefilled SyringeSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDdce1590f-9e47-4c4d-9437-cfb18b779a7512
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
2688826adalimumab-ryvk 40 MG per 0.4 ML Prefilled SyringeSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Medicated PadSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Topical ClothSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Topical SwabSYdce1590f-9e47-4c4d-9437-cfb18b779a7512
797544isopropyl alcohol 70 % Medicated PadPSN00b2c444-8601-4d8f-b6bb-91b864fd90418
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD00b2c444-8601-4d8f-b6bb-91b864fd90418
797544isopropyl alcohol 70 % Medicated PadSY00b2c444-8601-4d8f-b6bb-91b864fd90418
797544isopropyl alcohol 70 % Topical ClothSY00b2c444-8601-4d8f-b6bb-91b864fd90418
797544isopropyl alcohol 70 % Topical SwabSY00b2c444-8601-4d8f-b6bb-91b864fd90418
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSN2d19a877-1f5a-4731-800a-dddadc4240807
2706644adalimumab-ryvk 80 MG in 0.8 ML Auto-InjectorPSN2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 70 % Medicated PadPSN2d19a877-1f5a-4731-800a-dddadc4240807
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD2d19a877-1f5a-4731-800a-dddadc4240807
27066440.8 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCD2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2d19a877-1f5a-4731-800a-dddadc4240807
2677780adalimumab-ryvk 40 MG per 0.4 ML Auto-InjectorSY2d19a877-1f5a-4731-800a-dddadc4240807
2706644adalimumab-ryvk 80 MG per 0.8 ML Auto-InjectorSY2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 70 % Medicated PadSY2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 70 % Topical ClothSY2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 70 % Topical SwabSY2d19a877-1f5a-4731-800a-dddadc4240807
797544isopropyl alcohol 70 % Medicated PadPSN54586d75-a0a1-46aa-9cc9-631094320bff2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD54586d75-a0a1-46aa-9cc9-631094320bff2
797544isopropyl alcohol 70 % Medicated PadSY54586d75-a0a1-46aa-9cc9-631094320bff2
797544isopropyl alcohol 70 % Topical ClothSY54586d75-a0a1-46aa-9cc9-631094320bff2
797544isopropyl alcohol 70 % Topical SwabSY54586d75-a0a1-46aa-9cc9-631094320bff2
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
2677780adalimumab-ryvk 40 MG in 0.4 ML Auto-InjectorPSNba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1
2706644adalimumab-ryvk 80 MG in 0.8 ML Auto-InjectorPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 70 % Medicated PadPSNba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1
797544isopropyl alcohol 70 % Medicated PadPSNf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
2677787Simlandi 40 MG in 0.4 ML Auto-InjectorPSNba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1
26777870.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]SBDba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1
26777800.4 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
27066440.8 ML adalimumab-ryvk 100 MG/ML Auto-InjectorSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDf8c0d3c2-b5ed-4bb8-927c-5c5529343ee61
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDba9dd71c-13c9-4cfe-84a2-b4f17d1c583f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0002-2655170002021 mL in 1 POUCH (65517-0002-2) 1 ml2000-01-010000-00-00NoNoCurrent