Crown Solutions Instant Hand Sanitizer Gel

Product NDC
81570-001
Requested package NDC
81570-001-03
11-digit product format
815700001
Labeler code
81570
Product ID
81570-001_cbf7e393-eb90-b854-e053-2a95a90a9e0e
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
RAF, LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-09-04
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage81570-00181570-001-03IInactivated 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 · 15 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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81570-001-01Crown Solutions Instant Hand Sanitizer Gel24 in 1 BOXGEL241
81570-001-01Crown Solutions Instant Hand Sanitizer Gel118 mL in 1 BOTTLEGEL1181
81570-001-02Crown Solutions Instant Hand Sanitizer Gel236 mL in 1 BOTTLEGEL2361
81570-001-02Crown Solutions Instant Hand Sanitizer Gel24 in 1 BOXGEL241
81570-001-03Crown Solutions Instant Hand Sanitizer Gel4 in 1 BOXGEL41
81570-001-03Crown Solutions Instant Hand Sanitizer Gel946 mL in 1 BOTTLEGEL9461
81570-001-04Crown Solutions Instant Hand Sanitizer Gel3784 mL in 1 BOTTLEGEL37841
81570-001-04Crown Solutions Instant Hand Sanitizer Gel4 in 1 BOXGEL41
81570-001-05Crown Solutions Instant Hand Sanitizer Gel946000 mL in 1 TANKGEL9460001
81570-001-05Crown Solutions Instant Hand Sanitizer Gel1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81570-001CROWN SOLUTIONS INSTANT HAND SANITIZER GEL (ALCOHOL) GEL [RAF, LLC]1Legacy NDC, 10 package rows20210918_0403be03-d72e-4ec5-8fd8-0a0deb9cefbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN0403be03-d72e-4ec5-8fd8-0a0deb9cefbf1
581660ethanol 0.62 ML/ML Topical GelSCD0403be03-d72e-4ec5-8fd8-0a0deb9cefbf1
581660ethanol 62 % Topical GelSY0403be03-d72e-4ec5-8fd8-0a0deb9cefbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81570-001-03815700001034 BOTTLE in 1 BOX (81570-001-03) > 946 mL in 1 BOTTLE4 bottle2021-09-040000-00-00NoNoCurrent