FDA.reportPublic FDA data

Isagel

Product NDC
11701-025
11-digit product format
117010025
Labeler code
11701
Product ID
11701-025_48028c1c-0707-4208-8c36-ae2b25f3a59d
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Coloplast Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Marketing end
2026-11-30
Substance
ALCOHOL
Active strength
600 mL/1000mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11701-02511701-025-04DDiscontinued by firm2026-10-21
excluded packagepackage11701-02511701-025-45DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11701-025-459bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11701-025-45110d247fa046…a55b01930146…

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
Isagel

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL600 mL/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eba7e574-25c2-445a-98f6-2d1045455466Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
11701-025-042023-12-15f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-042023-12-15f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-12-15f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-12-15f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-452023-12-15960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452023-12-15960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-042023-01-30f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-042023-01-30f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-01-30f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-01-30f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-452023-01-30960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452023-01-30960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452020-06-18960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452020-06-18960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452019-10-29960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®
11701-025-452019-10-29960f7f55-c290-8e05-e053-dbdaa90a074aIsagel ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-025-04Isagel118 mL in 1 BOTTLEGEL11813
11701-025-26Isagel621 mL in 1 BOTTLEGEL62113
11701-025-45Isagel800 mL in 1 BAGGEL80010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-025-03ML - Milliliter11701-025fa5a4032-4c9c-46af-b1be-aa7bfa3ac1b712015-10-02
11701-025-04ML - Milliliter11701-0255664161c-2ef1-42b2-98e8-8142c5ec75f112013-02-13
11701-025-26ML - Milliliter11701-02591007fbc-1352-4650-ab69-c33e888ffd8412013-02-13
11701-025-45ML - Milliliter11701-0250996711d-75a2-4450-a230-b1f45b32158e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90MISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
AlcoholACTIVE MOIETY3K9958V90MISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N14ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]7
ALCOHOLACTIVE INGREDIENT3K9958V90MISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
ALCOHOLACTIVE MOIETY3K9958V90MISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N14ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-025ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]11Current NDC, Legacy NDC, 2 package rows20231216_eba7e574-25c2-445a-98f6-2d1045455466.zip
11701-025ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]8Current NDC, Legacy NDC, 1 package rows20231216_5be93a24-c644-4e6b-a600-87f0a5a09e5c.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 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSNeba7e574-25c2-445a-98f6-2d104545546613
581658ethanol 0.6 ML/ML Topical GelSCDeba7e574-25c2-445a-98f6-2d104545546613
581658ethanol 60 % Topical GelSYeba7e574-25c2-445a-98f6-2d104545546613
581658ethanol 60 % Topical GelPSN5be93a24-c644-4e6b-a600-87f0a5a09e5c10
581658ethanol 0.6 ML/ML Topical GelSCD5be93a24-c644-4e6b-a600-87f0a5a09e5c10
581658ethanol 60 % Topical GelSY5be93a24-c644-4e6b-a600-87f0a5a09e5c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-025-0411701002504118 mL in 1 BOTTLE (11701-025-04) 118 ml2009-06-150000-00-00NoNoCurrent
11701-025-2611701002526621 mL in 1 BOTTLE (11701-025-26) 621 ml2009-06-152026-11-30NoNoCurrent
11701-025-4511701002545800 mL in 1 BAG (11701-025-45) 800 ml2009-06-150000-00-00NoNoCurrent