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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11701-025	11701-025-04	D	Discontinued by firm		2026-10-16
excluded package	package	11701-025	11701-025-45	D	Discontinued by firm		2026-10-16

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	11701-025-45	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	11701-025-45	`110d247fa046…`	`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
Ingredient	Strength
ALCOHOL	600 mL/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
eba7e574-25c2-445a-98f6-2d1045455466	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
11701-025-04	2023-12-15	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-26	2023-12-15	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-45	2023-12-15	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-04	2023-01-30	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-26	2023-01-30	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-45	2023-01-30	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-45	2020-06-18	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-45	2019-10-29	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11701-025-04	Isagel	118 mL in 1 BOTTLE	GEL	118	13
11701-025-26	Isagel	621 mL in 1 BOTTLE	GEL	621	13
11701-025-45	Isagel	800 mL in 1 BAG	GEL	800	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-025-03	ML - Milliliter	11701-025	fa5a4032-4c9c-46af-b1be-aa7bfa3ac1b7	1	2015-10-02
11701-025-04	ML - Milliliter	11701-025	5664161c-2ef1-42b2-98e8-8142c5ec75f1	1	2013-02-13
11701-025-26	ML - Milliliter	11701-025	91007fbc-1352-4650-ab69-c33e888ffd84	1	2013-02-13
11701-025-45	ML - Milliliter	11701-025	0996711d-75a2-4450-a230-b1f45b32158e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Alcohol	ACTIVE INGREDIENT	3K9958V90M	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
Alcohol	ACTIVE MOIETY	3K9958V90M	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	7
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
ALCOHOL	ACTIVE MOIETY	3K9958V90M	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-025	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20231216_eba7e574-25c2-445a-98f6-2d1045455466.zip
11701-025	ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]	8	Current NDC, Legacy NDC, 1 package rows	20231216_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 45 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biopure Antibacterial Hand Wipe Berry Strawberry	BENZALKONIUM CHLORIDE	Quest USA Corp	47d6574c-0d4c-392e-e063-6394a90a590f	2026-01-07	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe Vallina Dream	BENZALKONIUM CHLORIDE	Quest USA Corp	47d7090d-036b-870b-e063-6394a90a80c3	2026-01-07	Warnings	Exact identifier application number: M003
99 Plus Hand Sanitizer	BENZEALKONIUM CHLORIDE	Momar Incorporated	f972a8f1-c928-4e4b-a8dd-a2fb77052d21	2026-01-06	Warnings	Exact identifier application number: M003
Benzocaine	BENZOCAINE	Dynarex Corporation	6161e94c-7849-466e-8da3-a6f1b085bdf9	2026-01-06	Warnings	Exact identifier application number: M003
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent	BENZALKONIUM CHLORIDE	Quest USA Corp	47c105a8-7c76-9cde-e063-6294a90a9284	2026-01-06	Warnings	Exact identifier application number: M003
SPA HAND SANITIZER VANILLA	ETHYL ALCOHOL	Rejoice International Corp.	47c3c187-da54-7c3b-e063-6294a90af3ce	2026-01-06	Warnings	Exact identifier application number: M003
SPA HAND SANITIZER CHAMPAGNE BLASH	ETHYL ALCOHOL	Rejoice International Corp.	47c5e9af-4ea8-fb39-e063-6394a90aa5ab	2026-01-06	Warnings	Exact identifier application number: M003
Antiseptic Cleaning wipe	ANTISEPTIC CLEANING WIPE	SHENZHEN BENLIJU BIO-TECH CO.,LTD	203d01ae-d99e-bce3-e063-6294a90a1a2d	2026-01-05	Warnings	Exact identifier application number: M003
Povidone-lodine prep pad	POVIDONE-LODINE PREP PAD	SHENZHEN BENLIJU BIO-TECH CO.,LTD	201545b8-0697-5601-e063-6394a90a12f4	2026-01-05	Warnings	Exact identifier application number: M003
Sting Relief prep Pad	STING RELIEF PREP PAD	SHENZHEN BENLIJU BIO-TECH CO.,LTD	202c7b77-1a48-52a5-e063-6394a90a2eb2	2026-01-05	Warnings	Exact identifier application number: M003
Skin Cleaning Care Wipes	SKIN CLEANING CARE WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	203d7a95-65fe-ca65-e063-6294a90acc6e	2026-01-05	Warnings	Exact identifier application number: M003
ANTISEPTIC CLEANSING WIPE(0.9% NACL)	ANTISEPTIC CLEANSING WIPE(0.9% NACL)	SHENZHEN BENLIJU BIO-TECH CO.,LTD	33e1c026-8a35-a47a-e063-6294a90a2406	2026-01-05	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	HAND SANITIZING WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	37487da6-4e0e-6625-e063-6394a90a0af1	2026-01-05	Warnings	Exact identifier application number: M003
Hand wipes	HAND WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	39f3acca-7275-88ca-e063-6394a90ad1a2	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Heaven	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47a0781b-9b25-f04b-e063-6294a90ae7e5	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Berry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47a16397-dff3-7d79-e063-6394a90a040f	2026-01-05	Warnings	Exact identifier application number: M003
IDOSWAB B	ISOPROPYL ALCOHOL	IDO PHARM	16d19630-b67a-f3e1-e063-6394a90a7429	2026-01-05	Warnings	Exact identifier application number: M003
Sure Comfort Alcohol Prep Pads	ISOPROPYL ALCOHOL	IDO PHARM	27def94b-d3a6-18b7-e063-6394a90a22a6	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Lemon Lime	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47aeaae9-740d-a28a-e063-6294a90a6460	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Calming Lavender	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47aeeef9-0eed-e7d0-e063-6394a90a6d31	2026-01-05	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581658	ethanol 60 % Topical Gel	PSN	eba7e574-25c2-445a-98f6-2d1045455466	13
581658	ethanol 0.6 ML/ML Topical Gel	SCD	eba7e574-25c2-445a-98f6-2d1045455466	13
581658	ethanol 60 % Topical Gel	SY	eba7e574-25c2-445a-98f6-2d1045455466	13
581658	ethanol 60 % Topical Gel	PSN	5be93a24-c644-4e6b-a600-87f0a5a09e5c	10
581658	ethanol 0.6 ML/ML Topical Gel	SCD	5be93a24-c644-4e6b-a600-87f0a5a09e5c	10
581658	ethanol 60 % Topical Gel	SY	5be93a24-c644-4e6b-a600-87f0a5a09e5c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-025-04	11701002504	118 mL in 1 BOTTLE (11701-025-04)	118 ml	2009-06-15	0000-00-00	No	No	Current
11701-025-26	11701002526	621 mL in 1 BOTTLE (11701-025-26)	621 ml	2009-06-15	2026-11-30	No	No	Current
11701-025-45	11701002545	800 mL in 1 BAG (11701-025-45)	800 ml	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISAGEL ®	Coloplast Corp \| Medline Industries, LP	2026-03-27	HUMAN OTC DRUG LABEL	13
Isagel ®	Coloplast Corp \| Medline Industries, LP	2026-03-27	HUMAN OTC DRUG LABEL	10