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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic Application	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	da436c35-a98f-4df7-9d23-885564734cef	2025-01-13	Warnings	Exact identifier application number: M003
Burn Treatment	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40	2025-01-13	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CMC Group Inc.	dcca50e6-0935-401d-a23e-be4d1231dde9	2025-01-13	Warnings	Exact identifier application number: M003
Refill 2	BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	45dde3f0-546c-4ec5-beb0-c3d0432f4983	2025-01-13	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	2025-01-13	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	CMC Group Inc.	6f4a4538-7522-4bcf-b3cf-8dea60438a4d	2025-01-13	Warnings	Exact identifier application number: M003
Refill 6	ALCOHOL, WATER	CMC Group, Inc.	7849ae59-5484-4b86-a0b9-ec9b93d9afe0	2025-01-13	Warnings	Exact identifier application number: M003
EVR Povidone lodine Wipe	POVIDONE LODINE	Changzhou Maokang Medical Products Co., Ltd.	2b57e301-74e0-e1db-e063-6294a90a6c18	2025-01-10	Warnings	Exact identifier application number: M003
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier application number: M003
Medzah Ditek Alcohol Prep Pads	ISOPROPYL ALCOHOL	Medzah Industries	4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac	2025-01-10	Warnings	Exact identifier application number: M003
Alcohol Prep Pad-Large	ISOPROPYL ALCOHOL	Global Biomedical Technologies, LLC	93d00515-e93f-48a3-b66b-7d933e734e54	2025-01-10	Warnings	Exact identifier application number: M003
DERMADIVE ULTRACARE - TETRAID	BENZALKONIUM CHLORIDE	Releaf Technologies LLC	025c0b33-73ca-334b-e063-6394a90ad668	2025-01-09	Warnings	Exact identifier application number: M003
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier application number: M003
BACTINE MAX	BACTINE MAX WOUND WASH	WellSpring Pharmaceutical Corporation	39b26c28-93e0-41a9-8018-f73525ebc015	2025-01-08	Warnings	Exact identifier application number: M003
sterile	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0658a0c8-f5ec-b380-e063-6394a90afff5	2025-01-08	Warnings	Exact identifier application number: M003
Betadine Surgical Scrub	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	1ad39e11-ea1e-44a4-8224-93f8135436c2	2025-01-06	Warnings	Exact identifier application number: M003
First Aid Antiseptic	BENZALKONIUM CHLORIDE	Water-Jel Technologies	2b3cb958-c0c4-47fd-8338-7c7821135f2b	2025-01-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ALCOHOL	Water-Jel Technologies	54e62104-8076-41db-afe5-6dc5c3563acc	2025-01-06	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