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 55 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Hand Sanitizer Sweet Pea	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	435ca082-0b6b-c55e-e063-6294a90af56e	2025-11-11	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Barbie	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	435d514e-204a-118b-e063-6294a90aa8a6	2025-11-11	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Spider-man	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	435d939c-9bef-bf86-e063-6394a90a4142	2025-11-11	Warnings	Exact identifier application number: M003
Foaming Hand Sanitizer	HAND SANITIZER	American Chemical Systems II, LLC	3085d595-68b7-4100-81c0-f0699a7609d6	2025-11-10	Warnings	Exact identifier application number: M003
Genuine First Aid Pain Relieving Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	GFA Production (Xiamen) Co., Ltd.	48867a79-4d21-4ba1-9cf9-7839352a4b7e	2025-11-07	Warnings	Exact identifier application number: M003
Pocket Nurse	ISOPROPYL ALCOHOL	Pocket Nurse Enterprises, LLC	42ded32e-15d9-8b03-e063-6394a90ad6bc	2025-11-06	Warnings	Exact identifier application number: M003
SMARTIES ORANGE HAND SANITIZER MIX BERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d5785f-a86b-47fb-e063-6294a90a7314	2025-11-05	Warnings	Exact identifier application number: M003
Sour Patch Kids Hand Sanitizer Blue Raspberry	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d5afab-e872-09e3-e063-6394a90abcc4	2025-11-05	Warnings	Exact identifier application number: M003
DASIY HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d632d1-17a9-b4cf-e063-6394a90a8468	2025-11-05	Warnings	Exact identifier application number: M003
DASIY HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d677a4-3cc2-a039-e063-6294a90a1672	2025-11-05	Warnings	Exact identifier application number: M003
Pain Relieving Cleansing	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	TARGET CORPORATION	944b3f78-3efa-484b-84f0-00ffe95c5dfb	2025-11-05	Warnings	Exact identifier application number: M003
Hand Sanitizer	SDA 40B ALCOHOL 200 PROOF	Tropical Seas, Inc.	b48f9afa-1634-e63e-e053-2a95a90a32bf	2025-11-04	Warnings	Exact identifier application number: M003
Smarties Orange Hand Sanitizer Raspberry Cream	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d22dff-dca4-ead3-e063-6394a90abdce	2025-11-04	Warnings	Exact identifier application number: M003
Smarties Hand Sanitizer Orange Creamsicle	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d1fdb7-0cae-edce-e063-6294a90a9a96	2025-11-04	Warnings	Exact identifier application number: M003
MyHealth Alcohol Antiseptic Hand Sanitizer	ALCOHOL	Aeroflex Industria de Aerosol Ltda	f8eeb819-ec48-41a4-920c-7cdae55d7ecd	2025-10-31	Warnings	Exact identifier application number: M003
MyHealth Advanced Hand Sanitizer	ALCOHOL	Aeroflex Industria de Aerosol Ltda	0e3b2c36-57d7-438b-a2fc-fa9f00d9a552	2025-10-31	Warnings	Exact identifier application number: M003
Nourishing Hand Sanitizer Orange Coriander	ALCOHOL SOLUTION	Noshinku	2fed43e6-cf3a-bf33-e063-6394a90a16cf	2025-10-31	Warnings	Exact identifier application number: M003
Coralite Antibacterial Moist	BENZALKONIUM CHLORIDE	United Exchange Corp.	6245a83f-5c81-4ae6-bc6e-adfc46c37003	2025-10-31	Warnings	Exact identifier application number: M003
Castellani Paint	PHENOL	Stratus Pharamceuticals	74192c0e-3c73-4ab0-96d1-1917cbd6777a	2025-10-30	Warnings	Exact identifier application number: M003
GrowDefender Antibacterial Foam	ANTIBACTERIAL FOAM	Grow Defender LLC	423af3d9-6413-c097-e063-6294a90ae1a9	2025-10-28	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