Isopropyl Alcohol

Product NDC: 0869-0804
11-digit product format: 008690804
Labeler code: 0869
Product ID: 0869-0804_5b8753f2-6a2c-2918-e063-6394a90af2b8
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Vi-Jon, LLC
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1989-07-15
Substance: ISOPROPYL ALCOHOL
Active strength: 91 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0869-0804	0869-0804-08	D	Discontinued by firm	2026-10-21
excluded package	package	0869-0804	0869-0804-45	D	Discontinued by firm	2026-10-21
excluded package	package	0869-0804	0869-0804-72	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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0869-0804-45	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0869-0804-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0869-0804-72	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0869-0804-45	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0869-0804-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0869-0804-72	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0869-0804-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0869-0804-72	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0869-0804-45	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0869-0804-08	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0869-0804-72	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0869-0804-45	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0869-0804-08	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0869-0804-72	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0869-0804-45	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0869-0804-08	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0869-0804-72	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0869-0804-45	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0869-0804-08	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0869-0804-72	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0869-0804-45	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0869-0804-08	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0869-0804-72	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0869-0804-45	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0869-0804-08	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0869-0804-72	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0869-0804-45	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0869-0804-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0869-0804-72	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0869-0804-45	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0869-0804-08	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0869-0804-72	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0869-0804-45	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0869-0804-08	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0869-0804-72	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0869-0804-45	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0869-0804-43	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0869-0804-45	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0869-0804-45	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0869-0804-43	E	Excluded after deficient or non-compliant submission was not corrected	`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: Isopropyl Alcohol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROPYL ALCOHOL	91 mL/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0869-0804-43	2020-09-16	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-43	2020-09-16	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-45	2020-09-16	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-45	2020-09-16	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-43	2020-01-31	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-43	2020-01-31	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-45	2020-01-31	Swan 804.003/804AA 91% Isopropyl Alcohol
0869-0804-45	2020-01-31	Swan 804.003/804AA 91% Isopropyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0869-0804-08	Isopropyl Alcohol	3785 mL in 1 BOTTLE, PLASTIC	LIQUID	3785	16
0869-0804-43	Isopropyl Alcohol	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473	16
0869-0804-45	Isopropyl Alcohol	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946	16
0869-0804-72	Isopropyl Alcohol	295 mL in 1 BOTTLE, SPRAY	LIQUID	295	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0869-0804-43	ML - Milliliter	0869-0804	4a9f248a-f231-4475-bb29-c1e00cef24f6	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC]	1
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0869-0804	ISOPROPYL ALCOHOL LIQUID [VI-JON, LLC]	14	Current NDC, Legacy NDC, 4 package rows	20240427_4df6e896-c3f7-4505-9814-9b791552b627.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health, Inc	bb7c530f-5d80-4158-b715-09c1c837299d	2024-11-21	Warnings	Exact identifier application number: M003
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health 200 LLC	10135db9-f614-4511-96ac-faa6a02a1b61	2024-11-21	Warnings	Exact identifier application number: M003
BZK Antiseptic Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	d9f35c14-2f5a-4e1a-bc2b-a7e163134213	2024-11-21	Warnings	Exact identifier application number: M003
Povidone-lodine Swabsticks Triple	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	74e70ea9-640b-4295-a40f-56f65fca1300	2024-11-21	Warnings	Exact identifier application number: M003
MK Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	37f10b1f-b73c-4d71-91c2-1252f3d9d4ce	2024-11-21	Warnings	Exact identifier application number: M003
BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	1936d749-bf38-a433-e063-6294a90aba8c	2024-11-21	Warnings	Exact identifier application number: M003
Maokang 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	7c17ce40-0358-44ff-aa60-53711666914b	2024-11-21	Warnings	Exact identifier application number: M003
MK Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	11390854-9e72-40a2-9c89-3c29a585dced	2024-11-21	Warnings	Exact identifier application number: M003
Instant Hand Sanitizeing Wipe	ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS	Shandong Yayun Sanitary Products Co., Ltd.	aa0dc01a-2c6b-7402-e053-2a95a90af6a2	2024-11-21	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Prep Solution	POVIDONE IODINE PREP SOLUTION	Dynarex Corporation	6bb4d55b-2be7-3549-e053-2a91aa0a2bb0	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Surgical Scrub	POVIDONE IODINE SURGICAL SCRUB SOLUTION	Dynarex Corporation	6f053e55-cbf6-9072-e053-2991aa0a2edd	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	ALCOHOL	Dynarex Corporation	072572be-49dd-4594-bc40-b56db57ada5b	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	CHLOROXYLENOL	Dynarex Corporation	59b098d2-08de-4fdb-a209-ae226abf37d6	2024-11-20	Warnings	Exact identifier application number: M003
Baby Wipes	PROPYLENE GLYCOL	Shandong Yayun Sanitary Products Co., Ltd.	aeb9a12c-955f-5030-e053-2995a90a2dd6	2024-11-20	Warnings	Exact identifier application number: M003
Pet wipes	BENZALKONIUM CHLORIDE	Shandong Yayun Sanitary Products Co., Ltd.	2764ea79-32d8-b7f6-e063-6394a90a5501	2024-11-20	Warnings	Exact identifier application number: M003
Premium Hand Sanitizer	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	a9514466-e0c6-4792-984a-9f07d94ee887	2024-11-18	Warnings	Exact identifier application number: M003
MARVEL BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	93ed0bb4-834d-44ca-9c0a-20086fc09ab8	2024-11-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	McKesson Medical-Surgical Inc.	98b0bcc2-539b-4471-ba98-bbe17bb881bd	2024-11-15	Warnings	Exact identifier application number: M003
CVS Health Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	CVS PHARMACY, INC	7a930a5e-5b69-428f-9cbb-d03dae180295	2024-11-12	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Prep Pad	POVIDONE-IODINE	Acme United Corporation	509b6c8e-6a9f-2656-e054-00144ff8d46c	2024-11-09	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
582901	isopropyl alcohol 91 % Topical Solution	PSN	4df6e896-c3f7-4505-9814-9b791552b627	16
582901	isopropyl alcohol 0.91 ML/ML Topical Solution	SCD	4df6e896-c3f7-4505-9814-9b791552b627	16
582901	isopropyl alcohol 91 % Topical Solution	SY	4df6e896-c3f7-4505-9814-9b791552b627	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0869-0804-08	00869080408	3785 mL in 1 BOTTLE, PLASTIC	3785 ml					Historical
0869-0804-43	00869080443	473 mL in 1 BOTTLE, PLASTIC (0869-0804-43)	473 ml	1989-07-15	0000-00-00	No	No	Current
0869-0804-45	00869080445	.946 L in 1 BOTTLE, PLASTIC (0869-0804-45)		1989-07-15	0000-00-00	No	No	Current
0869-0804-72	00869080472	.295 L in 1 BOTTLE, SPRAY (0869-0804-72)		1989-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Swan 804.003/804AA 91% Isopropyl Alcohol	Vi-Jon, LLC \| Nice-Pak Products, LLC	2026-09-15	HUMAN OTC DRUG LABEL	17