FDA.reportPublic FDA data

Ollie Hand Sanitizer

Product NDC
81634-001
Requested package NDC
81634-001-01
11-digit product format
816340001
Labeler code
81634
Product ID
81634-001_c24a04d2-b087-69dd-e053-2995a90aa329
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
F.P. Aromatics Singapore Pte Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage81634-00181634-001-01IInactivated by FDA2026-10-12

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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-30cfb33479-2d53-4925-9fdc-acf2e6e514ab
2024-01-30cfb33479-2d53-4925-9fdc-acf2e6e514ab
2023-04-11cfb33479-2d53-4925-9fdc-acf2e6e514ab
2023-01-30cfb33479-2d53-4925-9fdc-acf2e6e514ab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81634-001-01Ollie Hand Sanitizer30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81634-001OLLIE HAND SANITIZER (ALCOHOL) LIQUID [F.P. AROMATICS SINGAPORE PTE LTD]3Legacy NDC, 1 package rows20230412_cfb33479-2d53-4925-9fdc-acf2e6e514ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNcfb33479-2d53-4925-9fdc-acf2e6e514ab3
1041849ethanol 0.7 ML/ML Topical SpraySCDcfb33479-2d53-4925-9fdc-acf2e6e514ab3
1041849ethanol 70 % Topical SpraySYcfb33479-2d53-4925-9fdc-acf2e6e514ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81634-001-018163400010130 mL in 1 BOTTLE, GLASS (81634-001-01) 30 ml2021-04-010000-00-00NoNoCurrent