OnkoHealth Hand and surface sanitizer

Product NDC: 77283-001
11-digit product format: 772830001
Labeler code: 77283
Product ID: 77283-001_80665fc5-bfca-48b1-9a2a-54234028d3ff
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: ONKO PHARMACEUTICALS USA INC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-11
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77283-001		I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-01	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-02	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-03	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-04	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-05	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-06	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-07	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-08	I	Inactivated by FDA	2026-10-15
excluded package	package	77283-001	77283-001-09	I	Inactivated by FDA	2026-10-15

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 3 · 180 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77283-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77283-001-09	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
77283-001-01	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-02	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-03	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-04	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-05	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-06	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-07	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-08	c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-09	c8094f06-eca1-4025-a7f5-a4ad28df403b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77283-001-01	OnkoHealth Hand and surface sanitizer	100 mL in 1 BOTTLE, PLASTIC	LIQUID	100	4
77283-001-02	OnkoHealth Hand and surface sanitizer	150 mL in 1 BOTTLE, PLASTIC	LIQUID	150	4
77283-001-03	OnkoHealth Hand and surface sanitizer	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236	4
77283-001-04	OnkoHealth Hand and surface sanitizer	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473	4
77283-001-05	OnkoHealth Hand and surface sanitizer	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000	4
77283-001-06	OnkoHealth Hand and surface sanitizer	3790 mL in 1 BOTTLE, PLASTIC	LIQUID	3790	4
77283-001-07	OnkoHealth Hand and surface sanitizer	10000 mL in 1 BOTTLE, PLASTIC	LIQUID	10000	4
77283-001-08	OnkoHealth Hand and surface sanitizer	20000 mL in 1 BOTTLE, PLASTIC	LIQUID	20000	4
77283-001-09	OnkoHealth Hand and surface sanitizer	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77283-001	ONKOHEALTH HAND AND SURFACE SANITIZER (ALCOHOL) LIQUID [ONKO PHARMACEUTICALS USA INC.]	4	Legacy NDC, 9 package rows	20201124_c8094f06-eca1-4025-a7f5-a4ad28df403b.zip

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
1039339	ethanol 80 % Topical Solution	PSN	c8094f06-eca1-4025-a7f5-a4ad28df403b	4
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	c8094f06-eca1-4025-a7f5-a4ad28df403b	4
1039339	ethanol 80 % Topical Solution	SY	c8094f06-eca1-4025-a7f5-a4ad28df403b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77283-001-01	77283000101	100 mL in 1 BOTTLE, PLASTIC (77283-001-01)	100 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-02	77283000102	150 mL in 1 BOTTLE, PLASTIC (77283-001-02)	150 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-03	77283000103	236 mL in 1 BOTTLE, PLASTIC (77283-001-03)	236 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-04	77283000104	473 mL in 1 BOTTLE, PLASTIC (77283-001-04)	473 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-05	77283000105	1000 mL in 1 BOTTLE, PLASTIC (77283-001-05)	1000 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-06	77283000106	3790 mL in 1 BOTTLE, PLASTIC (77283-001-06)	3790 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-07	77283000107	10000 mL in 1 BOTTLE, PLASTIC (77283-001-07)	10000 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-08	77283000108	20000 mL in 1 BOTTLE, PLASTIC (77283-001-08)	20000 ml	2020-05-11	0000-00-00	No	No	Current
77283-001-09	77283000109	355 mL in 1 BOTTLE, PLASTIC (77283-001-09)	355 ml	2020-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OnkoHealth Hand and surface sanitizer	ONKO PHARMACEUTICALS USA INC. \| CALDINI KIMYA SANAYI VE TICARET LIMITED SIRKETI \| SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI	2020-11-20	HUMAN OTC DRUG LABEL	4