ONKO HEALTH ALCOHOL ANTISEPTIC WIPE

Product NDC
77283-002
Requested package NDC
77283-002-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77283-00277283-002-01IInactivated by FDA2026-10-05

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 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77283-002-01ONKO HEALTH ALCOHOL ANTISEPTIC WIPE5 mL in 1 NOT APPLICABLECLOTH52
77283-002-01ONKO HEALTH ALCOHOL ANTISEPTIC WIPE1 in 1 POUCHCLOTH12
77283-002-02ONKO HEALTH ALCOHOL ANTISEPTIC WIPE100 in 1 BOTTLE, PLASTICCLOTH1002
77283-002-02ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-03ONKO HEALTH ALCOHOL ANTISEPTIC WIPE120 in 1 BOTTLE, PLASTICCLOTH1202
77283-002-03ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-04ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-04ONKO HEALTH ALCOHOL ANTISEPTIC WIPE150 in 1 BOTTLE, PLASTICCLOTH1502
77283-002-05ONKO HEALTH ALCOHOL ANTISEPTIC WIPE350 in 1 BOTTLE, PLASTICCLOTH3502
77283-002-05ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-06ONKO HEALTH ALCOHOL ANTISEPTIC WIPE400 in 1 BOTTLE, PLASTICCLOTH4002
77283-002-06ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-07ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-07ONKO HEALTH ALCOHOL ANTISEPTIC WIPE450 in 1 BOTTLE, PLASTICCLOTH4502
77283-002-08ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-08ONKO HEALTH ALCOHOL ANTISEPTIC WIPE500 in 1 BOTTLE, PLASTICCLOTH5002
77283-002-09ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-09ONKO HEALTH ALCOHOL ANTISEPTIC WIPE550 in 1 BOTTLE, PLASTICCLOTH5502
77283-002-10ONKO HEALTH ALCOHOL ANTISEPTIC WIPE600 in 1 BOTTLE, PLASTICCLOTH6002
77283-002-10ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-11ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-11ONKO HEALTH ALCOHOL ANTISEPTIC WIPE700 in 1 BOTTLE, PLASTICCLOTH7002
77283-002-12ONKO HEALTH ALCOHOL ANTISEPTIC WIPE800 in 1 BOTTLE, PLASTICCLOTH8002
77283-002-12ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-13ONKO HEALTH ALCOHOL ANTISEPTIC WIPE900 in 1 BOTTLE, PLASTICCLOTH9002
77283-002-13ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-14ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-14ONKO HEALTH ALCOHOL ANTISEPTIC WIPE1000 in 1 BOTTLE, PLASTICCLOTH10002
77283-002-15ONKO HEALTH ALCOHOL ANTISEPTIC WIPE2000 in 1 BOTTLE, PLASTICCLOTH20002
77283-002-15ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-16ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-16ONKO HEALTH ALCOHOL ANTISEPTIC WIPE5000 in 1 BOTTLE, PLASTICCLOTH50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77283-002ONKO HEALTH ALCOHOL ANTISEPTIC WIPE (ALCOHOL, ISOPROPYL ALCOHOL) CLOTH [ONKO PHARMACEUTICALS USA INC.]2Legacy NDC, 32 package rows20201124_a7af4ea8-a84a-4431-92f7-181fabed98d6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77283-002-01772830002011 NOT APPLICABLE in 1 POUCH (77283-002-01) > 5 mL in 1 NOT APPLICABLE1 not applicable2020-07-130000-00-00NoNoCurrent