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 60 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Luxury Hand Sanitizer Cashmere Char	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41938c11-391c-0a55-e063-6394a90ad451	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Tea and Timber	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4193d08a-bc54-ef3b-e063-6294a90a0608	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41940273-689d-0f44-e063-6294a90a957f	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Vanilla Verdant	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41942841-faa9-114e-e063-6294a90a0e58	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Zen and Zest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	419441a8-a6df-e15d-e063-6294a90a02ae	2025-10-20	Warnings	Exact identifier application number: M003
CVS Alcohol Prep	ISOPROPYL ALCOHOL	CVS Pharmacy	7abc66f2-faf6-421c-9c3c-b69f5a587246	2025-10-20	Warnings	Exact identifier application number: M003
Gentian Violet	GENTIAN VIOLET	World Perfumes Inc	419cc9a2-bfde-a516-e063-6294a90a065c	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender Drift	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a2d051-4920-76ee-e063-6294a90a5d3c	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach Nectar	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a36bb3-a648-3b5b-e063-6394a90aa4df	2025-10-20	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL XXL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	ec81be59-94a5-4675-9047-e3e82d7ad761	2025-10-20	Warnings	Exact identifier application number: M003
ALCOHOL PREP PAD	ISOPROPYL ALCOHOL	Guangdong Comfort Medical Products Co., Ltd.	3a2dea43-8123-3fb7-e063-6294a90a5e50	2025-10-19	Warnings	Exact identifier application number: M003
ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	3a40a31d-4032-71ba-e063-6294a90a48dc	2025-10-19	Warnings	Exact identifier application number: M003
ANTIBACTERIAL BANDAGES	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	6e43b8b3-2d49-8f76-e053-2a91aa0affb0	2025-10-19	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft Berry	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	418fed84-d4ab-7352-e063-6294a90a6dab	2025-10-19	Warnings	Exact identifier application number: M003
BZK CLEANSER	BENZALKONIUM CHLORIDE	Geri-Gentle Corporation	415eb5fb-5f88-d2dd-e063-6394a90abe5d	2025-10-17	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Large	ISOPROPYL ALCOHOL	Medline Industries, LP	c9fae7b6-2f4b-490b-9b17-a7297e738069	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Medium	ISOPROPYL ALCOHOL	Medline Industries, LP	9a8584e1-b422-4b77-8464-4e022d578fad	2025-10-16	Warnings	Exact identifier application number: M003
Signature Select Pain Relieving	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	Safeway/Albartsons	3cab1b0c-4ffd-9c01-e063-6294a90ad15d	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep	ISOPROPYL ALCOHOL	Medline Industries, LP	b43c0bff-82f8-c18d-e053-2995a90a8716	2025-10-16	Warnings	Exact identifier application number: M003
Medline	BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE	Medline Industries, LP	b1059e68-b240-056c-e053-2995a90a61b2	2025-10-16	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