FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
78520-001
Requested package NDC
78520-001-12
11-digit product format
785200001
Labeler code
78520
Product ID
78520-001_a7defe38-5731-f41b-e053-2995a90a1a39
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Coral Industrial Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
71 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 packagepackage78520-00178520-001-12IInactivated 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 · 19 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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
78520-001-01a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-02a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-03a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-04a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-05a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-06a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-07a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-08a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-09a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-10a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-11a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-12a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-13a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-14a7debe03-0b63-2edf-e053-2a95a90a5336
78520-001-15a7debe03-0b63-2edf-e053-2a95a90a5336

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78520-001-01Hand Sanitizer2 mL in 1 BOTTLEGEL21
78520-001-02Hand Sanitizer5 mL in 1 BOTTLEGEL51
78520-001-03Hand Sanitizer10 mL in 1 BOTTLEGEL101
78520-001-04Hand Sanitizer30 mL in 1 BOTTLEGEL301
78520-001-05Hand Sanitizer50 mL in 1 BOTTLEGEL501
78520-001-06Hand Sanitizer60 mL in 1 BOTTLEGEL601
78520-001-07Hand Sanitizer80 mL in 1 BOTTLEGEL801
78520-001-08Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78520-001-09Hand Sanitizer120 mL in 1 BOTTLEGEL1201
78520-001-10Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78520-001-11Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78520-001-12Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78520-001-13Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
78520-001-14Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
78520-001-15Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78520-001HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [GUANGZHOU CORAL INDUSTRIAL CO., LTD.]1Legacy NDC, 15 package rows20200613_a7debe03-0b63-2edf-e053-2a95a90a5336.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78520-001-1278520000112500 mL in 1 BOTTLE (78520-001-12) 500 ml2020-06-100000-00-00NoNoCurrent