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		2026-10-21
excluded package	package	11701-025	11701-025-45	D	Discontinued by firm		2026-10-21

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 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 ®
11701-025-04	2023-12-15	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-26	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 ®
11701-025-45	2023-12-15	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-04	2023-01-30	f386c649-b6e2-0266-e053-dadaa90a7c1a	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 ®
11701-025-26	2023-01-30	f386c649-b6e2-0266-e053-dadaa90a7c1a	ISAGEL ®
11701-025-45	2023-01-30	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-45	2023-01-30	960f7f55-c290-8e05-e053-dbdaa90a074a	Isagel ®
11701-025-45	2020-06-18	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 ®
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 102 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	997d0ff0-96b4-4b91-87fc-8f67d9b5013c	2024-08-28	Warnings	Exact identifier application number: M003
hand sanitizer 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202dfeac-6e69-8667-e063-6294a90a26d2	2024-08-21	Warnings	Exact identifier application number: M003
antibacterial hand sanitizer gel 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202e5c15-8749-0a76-e063-6294a90a2720	2024-08-21	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS	Total Resources International, Inc	eacb5138-4af8-4550-b883-5603ad96ed7d	2024-08-16	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Antiseptic	POVIDONE-IODINE	Acme United Corporation	e0052ac2-4f74-32a4-e053-2995a90a94c6	2024-08-13	Warnings	Exact identifier application number: M003
Keep Going Sting Relief Pad	BENZOCAINE AND ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	36c11178-b70f-4355-8823-c2b72598dae5	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Non Sting Cleaning Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	6b7400d5-d4b8-4b68-b048-c1917cdf3ce3	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Alcohol Prep Pad	ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	f67dd10c-746f-4c21-92f1-741f86218a69	2024-08-08	Warnings	Exact identifier application number: M003
Sugar Cookie Sanitizer 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efc0e9e-b4eb-d2b0-e063-6394a90a7779	2024-08-06	Warnings	Exact identifier application number: M003
Lemon Lime Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efe7236-d7bd-2a1c-e063-6294a90a736e	2024-08-06	Warnings	Exact identifier application number: M003
Maokang Medical 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	644e92c3-3043-4a76-9845-7e0482cf9f62	2024-07-19	Warnings	Exact identifier application number: M003
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	Smith & Nephew Medical Ltd.	18704cd5-1ecf-4e8c-9897-7e45394e68c8	2024-07-15	Warnings	Exact identifier application number: M003
Novex Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	7832a0be-a8ce-4b56-a9bb-a375b97df287	2024-07-10	Warnings	Exact identifier application number: M003
Callington Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	00ca48ca-893d-4a3f-ad90-119522664e08	2024-07-10	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Grape 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1c9095ad-ce19-3666-e063-6394a90ae22d	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb78ed-36f9-a7d2-e063-6394a90a6477	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb9671-1970-39f9-e063-6294a90ac079	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbc68e-2b6b-768c-e063-6294a90a643b	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbbc55-3f7d-76d1-e063-6294a90a5590	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb701f7-61c8-e5f4-e063-6294a90a0c3c	2024-07-08	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