Home NDC 77283-002-09 ONKO HEALTH ALCOHOL ANTISEPTIC WIPE
Product NDC 77283-002
Requested package NDC 77283-002-09
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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…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 NDC Product Description Form Quantity Strength 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 77283-002-09 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