Hand Sanitizer

Product NDC
78359-001
Requested package NDC
78359-001-07
11-digit product format
783590001
Labeler code
78359
Product ID
78359-001_a67ca128-3de5-4219-e053-2995a90aa35a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Junior Chemical Products Care S.A. de C.V.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage78359-00178359-001-07IInactivated 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
78359-001-01Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
78359-001-02Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78359-001-03Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37801
78359-001-04Hand Sanitizer200000 mL in 1 DRUMGEL2000001
78359-001-05Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
78359-001-06Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1251
78359-001-07Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
78359-001-08Hand Sanitizer1000000 mL in 1 DRUMGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78359-001HAND SANITIZER (ALCOHOL) GEL [JUNIOR CHEMICAL PRODUCTS CARE S.A. DE C.V.]1Legacy NDC, 8 package rows20200626_a67cac96-b8bd-9882-e053-2995a90a25a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa67cac96-b8bd-9882-e053-2995a90a25a51
581662ethanol 0.7 ML/ML Topical GelSCDa67cac96-b8bd-9882-e053-2995a90a25a51
581662ethanol 70 % Topical GelSYa67cac96-b8bd-9882-e053-2995a90a25a51
581662ethyl alcohol 70 % Topical GelSYa67cac96-b8bd-9882-e053-2995a90a25a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78359-001-0778359000107250 mL in 1 BOTTLE, PLASTIC (78359-001-07) 250 ml2020-03-300000-00-00NoNoCurrent