FDA.reportPublic FDA data

Purox Hand Sanitizer

Product NDC
78186-001
Requested package NDC
78186-001-04
11-digit product format
781860001
Labeler code
78186
Product ID
78186-001_9bcaa2ca-5c16-4c57-a4d5-ee81f77f30c8
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Purox
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-22
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
85 L/100L
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 packagepackage78186-00178186-001-04IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
78186-001-01d6a99b39-5c7a-a426-e053-dadaa90af4c2f1b29e3a-2b74-4e50-87dc-9c0b629a3615
78186-001-02d6a99b39-f81d-a426-e053-dadaa90af4c233267621-bbf0-45a5-96f8-ee37e011619e
78186-001-03d6a99b39-5d46-a426-e053-dadaa90af4c204c5cb02-d1bf-45fb-9171-6ebdfda3a602
78186-001-04d6a99b39-f820-a426-e053-dadaa90af4c237339213-24de-46af-bea3-be07d9c732e8
78186-001-05d6a99b39-4c79-a426-e053-dadaa90af4c2abae7121-42bb-4bb8-a655-ca6667b4f9db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78186-001-01Purox Hand Sanitizer1.89 L in 1 BOTTLEGEL1.891
78186-001-02Purox Hand Sanitizer0.384 L in 1 BOTTLEGEL0.3841
78186-001-03Purox Hand Sanitizer0.473 L in 1 BOTTLEGEL0.4731
78186-001-04Purox Hand Sanitizer3.785 L in 1 BOTTLEGEL3.7851
78186-001-05Purox Hand Sanitizer0.118 L in 1 BOTTLEGEL0.1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78186-001PUROX HAND SANITIZER (ALCOHOL) GEL [PUROX]1Legacy NDC, 1 package rows20200716_04c5cb02-d1bf-45fb-9171-6ebdfda3a602.zip
78186-001PUROX HAND SANITIZER (ALCOHOL) GEL [PUROX]1Legacy NDC, 1 package rows20200716_37339213-24de-46af-bea3-be07d9c732e8.zip
78186-001PUROX HAND SANITIZER (ALCOHOL) GEL [PUROX]1Legacy NDC, 1 package rows20201224_abae7121-42bb-4bb8-a655-ca6667b4f9db.zip
78186-001PUROX HAND SANITIZER (ALCOHOL) GEL [PUROX]1Legacy NDC, 1 package rows20200716_33267621-bbf0-45a5-96f8-ee37e011619e.zip
78186-001PUROX HAND SANITIZER (ALCOHOL) GEL [PUROX]1Legacy NDC, 1 package rows20200708_f1b29e3a-2b74-4e50-87dc-9c0b629a3615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041851ethanol 85 % Topical GelPSN04c5cb02-d1bf-45fb-9171-6ebdfda3a6021
1041851ethanol 85 % Topical GelPSN33267621-bbf0-45a5-96f8-ee37e011619e1
1041851ethanol 85 % Topical GelPSN37339213-24de-46af-bea3-be07d9c732e81
1041851ethanol 85 % Topical GelPSNabae7121-42bb-4bb8-a655-ca6667b4f9db1
1041851ethanol 85 % Topical GelPSNf1b29e3a-2b74-4e50-87dc-9c0b629a36151
1041851ethanol 0.85 ML/ML Topical GelSCD04c5cb02-d1bf-45fb-9171-6ebdfda3a6021
1041851ethanol 0.85 ML/ML Topical GelSCD33267621-bbf0-45a5-96f8-ee37e011619e1
1041851ethanol 0.85 ML/ML Topical GelSCD37339213-24de-46af-bea3-be07d9c732e81
1041851ethanol 0.85 ML/ML Topical GelSCDabae7121-42bb-4bb8-a655-ca6667b4f9db1
1041851ethanol 0.85 ML/ML Topical GelSCDf1b29e3a-2b74-4e50-87dc-9c0b629a36151
1041851ethanol 85 % Topical GelSY04c5cb02-d1bf-45fb-9171-6ebdfda3a6021
1041851ethanol 85 % Topical GelSY33267621-bbf0-45a5-96f8-ee37e011619e1
1041851ethanol 85 % Topical GelSY37339213-24de-46af-bea3-be07d9c732e81
1041851ethanol 85 % Topical GelSYabae7121-42bb-4bb8-a655-ca6667b4f9db1
1041851ethanol 85 % Topical GelSYf1b29e3a-2b74-4e50-87dc-9c0b629a36151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78186-001-04781860001043.785 L in 1 BOTTLE (78186-001-04) 3.785 l2020-07-080000-00-00NoNoCurrent