ONKO HEALTH ALCOHOL ANTISEPTIC WIPE

Product NDC: 77283-002
11-digit product format: 772830002
Labeler code: 77283
Product ID: 77283-002_9fd30434-f484-45db-adfd-1e974cbc6333
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL, ISOPROPYL ALCOHOL
Dosage form: CLOTH
Route: TOPICAL
Labeler: ONKO PHARMACEUTICALS USA INC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-13
Marketing end: 0000-00-00
Substance: ALCOHOL; ISOPROPYL ALCOHOL
Active strength: 60 mL/100mL; 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 · 17 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77283-002		I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-01	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-02	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-03	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-04	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-05	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-06	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-07	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-08	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-09	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-10	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-11	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-12	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-13	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-14	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-15	I	Inactivated by FDA	2026-10-05
excluded package	package	77283-002	77283-002-16	I	Inactivated by FDA	2026-10-05

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 6 · 306 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	77283-002-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77283-002-12	`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	77283-002-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77283-002-12	`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	77283-002-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77283-002-12	`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	77283-002-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77283-002-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
77283-002-01	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-02	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-03	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-04	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-05	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-06	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-07	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-08	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-09	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-10	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-11	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-12	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-13	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-14	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-15	a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-16	a7af4ea8-a84a-4431-92f7-181fabed98d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77283-002-01	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	5 mL in 1 NOT APPLICABLE	CLOTH	5	2
77283-002-01	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	1 in 1 POUCH	CLOTH	1	2
77283-002-02	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	100 in 1 BOTTLE, PLASTIC	CLOTH	100	2
77283-002-02	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-03	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	120 in 1 BOTTLE, PLASTIC	CLOTH	120	2
77283-002-03	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-04	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-04	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	150 in 1 BOTTLE, PLASTIC	CLOTH	150	2
77283-002-05	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	350 in 1 BOTTLE, PLASTIC	CLOTH	350	2
77283-002-05	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-06	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	400 in 1 BOTTLE, PLASTIC	CLOTH	400	2
77283-002-06	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-07	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-07	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	450 in 1 BOTTLE, PLASTIC	CLOTH	450	2
77283-002-08	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-08	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	500 in 1 BOTTLE, PLASTIC	CLOTH	500	2
77283-002-09	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-09	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	550 in 1 BOTTLE, PLASTIC	CLOTH	550	2
77283-002-10	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	600 in 1 BOTTLE, PLASTIC	CLOTH	600	2
77283-002-10	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-11	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-11	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	700 in 1 BOTTLE, PLASTIC	CLOTH	700	2
77283-002-12	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	800 in 1 BOTTLE, PLASTIC	CLOTH	800	2
77283-002-12	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-13	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	900 in 1 BOTTLE, PLASTIC	CLOTH	900	2
77283-002-13	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-14	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-14	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	1000 in 1 BOTTLE, PLASTIC	CLOTH	1000	2
77283-002-15	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	2000 in 1 BOTTLE, PLASTIC	CLOTH	2000	2
77283-002-15	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-16	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	3.12 mL in 1 NOT APPLICABLE	CLOTH	3.12	2
77283-002-16	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE	5000 in 1 BOTTLE, PLASTIC	CLOTH	5000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77283-002	ONKO HEALTH ALCOHOL ANTISEPTIC WIPE (ALCOHOL, ISOPROPYL ALCOHOL) CLOTH [ONKO PHARMACEUTICALS USA INC.]	2	Legacy NDC, 32 package rows	20201124_a7af4ea8-a84a-4431-92f7-181fabed98d6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77283-002-01	77283000201	1 NOT APPLICABLE in 1 POUCH (77283-002-01) > 5 mL in 1 NOT APPLICABLE	1 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-02	77283000202	100 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-02) > 3.12 mL in 1 NOT APPLICABLE	100 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-03	77283000203	120 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-03) > 3.12 mL in 1 NOT APPLICABLE	120 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-04	77283000204	150 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-04) > 3.12 mL in 1 NOT APPLICABLE	150 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-05	77283000205	350 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-05) > 3.12 mL in 1 NOT APPLICABLE	350 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-06	77283000206	400 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-06) > 3.12 mL in 1 NOT APPLICABLE	400 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-07	77283000207	450 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-07) > 3.12 mL in 1 NOT APPLICABLE	450 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-08	77283000208	500 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-08) > 3.12 mL in 1 NOT APPLICABLE	500 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-09	77283000209	550 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-09) > 3.12 mL in 1 NOT APPLICABLE	550 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-10	77283000210	600 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-10) > 3.12 mL in 1 NOT APPLICABLE	600 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-11	77283000211	700 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-11) > 3.12 mL in 1 NOT APPLICABLE	700 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-12	77283000212	800 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-12) > 3.12 mL in 1 NOT APPLICABLE	800 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-13	77283000213	900 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-13) > 3.12 mL in 1 NOT APPLICABLE	900 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-14	77283000214	1000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-14) > 3.12 mL in 1 NOT APPLICABLE	1000 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-15	77283000215	2000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-15) > 3.12 mL in 1 NOT APPLICABLE	2000 not applicable	2020-07-13	0000-00-00	No	No	Current
77283-002-16	77283000216	5000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-16) > 3.12 mL in 1 NOT APPLICABLE	5000 not applicable	2020-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALCOHOL - ONKO PHARMACEUTICALS USA INC. \| SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI	ONKO PHARMACEUTICALS USA INC. \| SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI	2020-11-20	HUMAN OTC DRUG LABEL	2