FDA.reportPublic FDA data

ACCURATE LABS ANTISEPTIC HAND SANITIZER

Product NDC
78434-100
11-digit product format
784340100
Labeler code
78434
Product ID
78434-100_576df427-f9eb-4f3f-a5d0-ee443a6ea797
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Accurate Labs, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-01
Marketing end
2025-06-30
Substance
ALCOHOL
Active strength
80 L/100L
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct78434-100DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-02DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-04DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-08DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-16DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-32DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-64DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-70DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-75DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-80DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-85DDiscontinued by firm2026-10-05
excluded packagepackage78434-10078434-100-90DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78434-100-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78434-100-90f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78434-100ACCURATE LABS ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [ACCURATE LABS, LLC]2Legacy NDC20211008_4f337431-5c0e-419f-8377-846454811610.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78434-100-0278434010002.059 L in 1 BOTTLE, PUMP (78434-100-02) 2020-06-012025-06-30NoNoCurrent
78434-100-0478434010004.118 L in 1 BOTTLE, PUMP (78434-100-04) 2020-06-012025-06-30NoNoCurrent
78434-100-0878434010008.236 L in 1 BOTTLE, PUMP (78434-100-08) 2020-06-010000-00-00NoNoCurrent
78434-100-1678434010016.473 L in 1 BOTTLE, PUMP (78434-100-16) 2020-06-010000-00-00NoNoCurrent
78434-100-3278434010032.946 L in 1 BOTTLE, PUMP (78434-100-32) 2020-06-012025-06-30NoNoCurrent
78434-100-64784340100641.89 L in 1 CONTAINER (78434-100-64) 1.89 l2020-06-012025-06-30NoNoCurrent
78434-100-70784340100703.79 L in 1 CONTAINER (78434-100-70) 3.79 l2020-06-012025-06-30NoNoCurrent
78434-100-75784340100759.46 L in 1 CONTAINER (78434-100-75) 9.46 l2020-06-012025-06-30NoNoCurrent
78434-100-807843401008018.93 L in 1 CONTAINER (78434-100-80) 18.93 l2020-06-012025-06-30NoNoCurrent
78434-100-8578434010085208.2 L in 1 CONTAINER (78434-100-85) 208.2 l2020-06-012025-06-30NoNoCurrent
78434-100-90784340100901211.33 L in 1 CONTAINER (78434-100-90) 1211.33 l2020-06-012025-06-30NoNoCurrent