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 firm2026-10-20
excluded packagepackage11701-02511701-025-45DDiscontinued by firm2026-10-20

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 79 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Pharma-C Company 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEKleen Test Products Corporation7d1c94b1-66bd-4f22-beec-4975efd6b8162025-04-30WarningsExact identifier
application number: M003
POVIDONE-IODINE PREP PADS MEDIUMPOVIDONE-IODINE PREP PADS MEDIUMHF Acquisition Co. LLC, DBA HealthFirst33f08f03-93fb-214d-e063-6394a90a73bd2025-04-29WarningsExact identifier
application number: M003
SANSPRAYANTIBACTERIAL SANITIZER SPRAYBeacon Promotions Inc0e243179-37f6-45dc-e063-6394a90a5f802025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs7184b9ad-0125-413d-b054-f46239b8ca922025-04-28WarningsExact identifier
application number: M003
Pink Pineapple SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.73543eed-e022-4d51-b606-000dcc0232982025-04-28WarningsExact identifier
application number: M003
Vanilla Sugar SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.6c790c49-7b4a-4e07-b5ce-9a31db84e01f2025-04-28WarningsExact identifier
application number: M003
Strawberry Pound Cake SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.34750790-4eec-4a2d-9686-2c69c1db79e62025-04-28WarningsExact identifier
application number: M003
Sweet Coconut SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.f9062bbc-8534-4dcc-920a-19f13d1c0def2025-04-28WarningsExact identifier
application number: M003
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
application number: M003
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
application number: M003
Clear DefenseHAND SANITIZING WIPESMelaleuca, Inc.30dec472-8112-37d6-e063-6294a90a1f252025-04-24WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
application number: M003
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
application number: M003
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsExact identifier
application number: M003
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsExact identifier
application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18720bd0-6ea8-2d1b-e063-6394a90abe2d2025-04-23WarningsExact identifier
application number: M003
E-2 HAND ITEM 1095CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18728ebb-c416-5efe-e063-6294a90abd912025-04-23WarningsExact identifier
application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871b1db-f881-e7fd-e063-6294a90ada982025-04-23WarningsExact identifier
application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1870b08e-e5c3-7888-e063-6394a90a1c822025-04-23WarningsExact 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