FDA.reportPublic FDA data

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77283-002-012022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-022022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-032022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-042022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-052022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-062022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-072022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-082022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-092022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-102022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-112022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-122022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-132022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-142022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-152022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-162022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6

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
77283-002-0277283000202100 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-02) > 3.12 mL in 1 NOT APPLICABLE100 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0377283000203120 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-03) > 3.12 mL in 1 NOT APPLICABLE120 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0477283000204150 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-04) > 3.12 mL in 1 NOT APPLICABLE150 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0577283000205350 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-05) > 3.12 mL in 1 NOT APPLICABLE350 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0677283000206400 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-06) > 3.12 mL in 1 NOT APPLICABLE400 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0777283000207450 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-07) > 3.12 mL in 1 NOT APPLICABLE450 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0877283000208500 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-08) > 3.12 mL in 1 NOT APPLICABLE500 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-0977283000209550 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-09) > 3.12 mL in 1 NOT APPLICABLE550 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-1077283000210600 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-10) > 3.12 mL in 1 NOT APPLICABLE600 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-1177283000211700 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-11) > 3.12 mL in 1 NOT APPLICABLE700 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-1277283000212800 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-12) > 3.12 mL in 1 NOT APPLICABLE800 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-1377283000213900 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-13) > 3.12 mL in 1 NOT APPLICABLE900 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-14772830002141000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-14) > 3.12 mL in 1 NOT APPLICABLE1000 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-15772830002152000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-15) > 3.12 mL in 1 NOT APPLICABLE2000 not applicable2020-07-130000-00-00NoNoCurrent
77283-002-16772830002165000 NOT APPLICABLE in 1 BOTTLE, PLASTIC (77283-002-16) > 3.12 mL in 1 NOT APPLICABLE5000 not applicable2020-07-130000-00-00NoNoCurrent