Isopropyl Alcohol

Product NDC: 61010-5500
11-digit product format: 610105500
Labeler code: 61010
Product ID: 61010-5500_3bdedf7b-d99b-fa9e-e063-6294a90aa631
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl Alcohol
Dosage form: SPRAY
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-16
Substance: ISOPROPYL ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 38 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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61010-5500-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61010-5500-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61010-5500-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61010-5500-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61010-5500-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61010-5500-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61010-5500-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61010-5500-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61010-5500-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61010-5500-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61010-5500-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61010-5500-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61010-5500-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61010-5500-2	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61010-5500-2	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61010-5500-2	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61010-5500-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
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	61010-5500-2	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	61010-5500-2	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROPYL ALCOHOL	70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ND2M416302	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014638	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
89310a64-c4cc-46c6-8294-c4d28cd88118	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-08-08	Isopropyl alcohol, 70% 2oz. Bottle
2022-01-28	Isopropyl alcohol, 70% 2oz. Bottle
2021-02-04	Isopropyl alcohol, 70% 2oz. Bottle
2020-01-31	Isopropyl alcohol, 70% 2oz. Bottle

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-5500-2	Isopropyl Alcohol	59.1 mL in 1 BOTTLE, SPRAY	SPRAY	59.1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
isopropyl alcohol	ACTIVE INGREDIENT	ND2M416302	ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]	1
isopropyl alcohol	ACTIVE MOIETY	ND2M416302	ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5500	ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20210204_89310a64-c4cc-46c6-8294-c4d28cd88118.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 67 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Kids Hand Sanitizer My Little Pony	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e45fe7d-b30c-9273-e063-6294a90ae8e1	2025-09-08	Warnings	Exact identifier application number: M003
Smart Care Kids Hand Sanitizer Peppa pig	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e466475-351f-614e-e063-6394a90ab25a	2025-09-08	Warnings	Exact identifier application number: M003
Smart Care Kids Hand Sanitizer Squishmallows	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e46fe11-247f-36ad-e063-6294a90a1dd4	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Super Stat Blood Clotting First Aid	BENZETHONIUM CHLORIDE AND LIDOCAINE	Unifirst First Aid Corporation	47355df2-de67-4cf9-b367-645228e494ce	2025-09-08	Warnings	Exact identifier application number: M003
Blood Clotting First Aid	BENZETHONIUM CHLORIDE AND LIDOCAINE	Unifirst First Aid Corporation	2e544963-aa49-49cd-837e-9d89d86e257f	2025-09-08	Warnings	Exact identifier application number: M003
Medi-first Protective Coating Bandage	BENZETHONIUM CHLORIDE AND BENZOCAINE	Unifirst First Aid Corporation	05b0aef9-1553-4e95-8798-f41e5999bb46	2025-09-08	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	3f7fb451-e701-4aa8-814e-ceeb5c2198d9	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Plus Alcohol Wipes	70% ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	3f507990-282a-4b26-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Sterile Alcohol Wipes	ISOPROPYL ALCOHOL 70%	Unifirst First Aid Corporation	570baa70-e519-328b-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Plus Antiseptic Wipes	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	5743634b-f329-5fec-e053-2991aa0a751d	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic Wipes	BENZALKONIUM CHLORIDE	UniFirst First Aid Corporation	1bdd57c3-cdaf-a085-e063-6394a90a1e3d	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic Wipes	BENZALKONIUM CHLORIDE	Uniforst First Aid Corporation	5744f9a2-35c6-37df-e053-2991aa0a1ca9	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic Wipes	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	d2ccdd9a-469e-18eb-e053-2995a90a1196	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Alcohol Wipes	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	ce650cb6-5398-29e7-e053-2995a90ac797	2025-09-08	Warnings	Exact identifier application number: M003
MediFirst Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	8d17a840-b655-4e03-bc16-8ba033c3368d	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Sting Relief	BENZOCAINE 6%, ISOPROPYL ALCOHOL 60%	Unifirst First Aid Corporation	6e610821-b030-930b-e053-2a91aa0a66f9	2025-09-08	Warnings	Exact identifier application number: M003
Burn with Lidocaine	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	81363387-d4b1-4c3f-b67f-5017361c0fcd	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Isopropyl Alcohol	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	dbee035e-094f-f8a3-e053-2995a90a6620	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Isopropyl Alcohol 70%	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	dbfbf8cf-201b-2277-e053-2995a90a6e45	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First PVP Iodine Wipes	POVIDONE IODINE 10%	Unifirst-First Aid	406b4a37-816a-5ea4-e054-00144ff88e88	2025-09-08	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
1014638	isopropyl alcohol 70 % Topical Spray	PSN	89310a64-c4cc-46c6-8294-c4d28cd88118	4
1014638	isopropyl alcohol 0.7 ML/ML Topical Spray	SCD	89310a64-c4cc-46c6-8294-c4d28cd88118	4
1014638	isopropyl alcohol 70 % Topical Spray	SY	89310a64-c4cc-46c6-8294-c4d28cd88118	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-5500-2	61010550002	59.1 mL in 1 BOTTLE, SPRAY (61010-5500-2)	59.1 ml	2012-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isopropyl alcohol, 70% 2oz. Bottle	Safetec of America, Inc.	2025-08-08	HUMAN OTC DRUG LABEL	4
First Aid Only Isopropyl Alcohol 70% (Spray)	Acme United Corporation	2023-01-10	HUMAN OTC DRUG LABEL	1