FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
69964-0012
11-digit product format
699640012
Labeler code
69964
Product ID
69964-0012_a33b38dc-f102-75c0-e053-2995a90aee2f
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer Spray
Dosage form
SPRAY
Route
TOPICAL
Labeler
XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-14
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69964-0012IInactivated by FDA2026-10-16
excluded packagepackage69964-001269964-0012-1IInactivated by FDA2026-10-16
excluded packagepackage69964-001269964-0012-2IInactivated by FDA2026-10-16
excluded packagepackage69964-001269964-0012-3IInactivated by FDA2026-10-16
excluded packagepackage69964-001269964-0012-4IInactivated by FDA2026-10-16

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 2 of 2 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69964-0012-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69964-0012-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69964-0012-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69964-0012-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69964-0012-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69964-0012-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69964-0012-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69964-0012-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69964-0012-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69964-0012-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69964-0012-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69964-0012-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69964-0012-4fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69964-0012-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69964-0012-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69964-0012-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69964-0012-486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69964-0012-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69964-0012-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69964-0012-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69964-0012-4bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69964-0012-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69964-0012-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69964-0012-2bd6a592717d7…303034d00443…

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
69964-0012-1Hand sanitizer spray
69964-0012-2Hand sanitizer spray
69964-0012-3Hand sanitizer spray
69964-0012-4Hand sanitizer spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69964-0012-1Hand Sanitizer15 mL in 1 BOTTLESPRAY151
69964-0012-2Hand Sanitizer20 mL in 1 BOTTLESPRAY201
69964-0012-3Hand Sanitizer60 mL in 1 BOTTLESPRAY601
69964-0012-4Hand Sanitizer120 mL in 1 BOTTLESPRAY1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69964-0012HAND SANITIZER (HAND SANITIZER SPRAY) SPRAY [XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD]1Legacy NDC, 4 package rows20200505_a4b5f366-c72e-6cbb-e053-2a95a90af9a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNa4b5f366-c72e-6cbb-e053-2a95a90af9a51
1041849ethanol 0.7 ML/ML Topical SpraySCDa4b5f366-c72e-6cbb-e053-2a95a90af9a51
1041849ethanol 70 % Topical SpraySYa4b5f366-c72e-6cbb-e053-2a95a90af9a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69964-0012-16996400120115 mL in 1 BOTTLE (69964-0012-1) 15 ml2020-04-140000-00-00NoNoCurrent
69964-0012-26996400120220 mL in 1 BOTTLE (69964-0012-2) 20 ml2020-04-140000-00-00NoNoCurrent
69964-0012-36996400120360 mL in 1 BOTTLE (69964-0012-3) 60 ml2020-04-140000-00-00NoNoCurrent
69964-0012-469964001204120 mL in 1 BOTTLE (69964-0012-4) 120 ml2020-04-140000-00-00NoNoCurrent