FDA.reportPublic FDA data

PALMA HAND SANITIZER

Product NDC
81286-101
Requested package NDC
81286-101-10
11-digit product format
812860101
Labeler code
81286
Product ID
81286-101_9e07b73e-28a0-4a4b-8c57-32d9a15c8e06
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
UNITRADE FZE
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-07-26
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage81286-10181286-101-10IInactivated 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage81286-10181286-101-10IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81286-101-102022-11-16C16284748780-1e4f33bdf-a8b7-d8a0-e053-dadaa90a6e4ePALMA DE SALUS HAND SANITIZER
81286-101-102022-07-29C16284748780-1e4f33bdf-a8b7-d8a0-e053-dadaa90a6e4ePALMA DE SALUS HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81286-101-10PALMA HAND SANITIZER325 mL in 1 BOTTLE, PUMPGEL3253
81286-101-10PALMA HAND SANITIZER1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81286-101PALMA HAND SANITIZER (ETHYL ALCOHOL) GEL [UNITRADE FZE]3Legacy NDC, 2 package rows20241222_6d35fbce-e9ae-45df-84ef-43188a0f4230.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN6d35fbce-e9ae-45df-84ef-43188a0f42303
581662ethanol 0.7 ML/ML Topical GelSCD6d35fbce-e9ae-45df-84ef-43188a0f42303
581662ethanol 70 % Topical GelSY6d35fbce-e9ae-45df-84ef-43188a0f42303
581662ethyl alcohol 70 % Topical GelSY6d35fbce-e9ae-45df-84ef-43188a0f42303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81286-101-10812860101101 BOTTLE, PUMP in 1 CARTON (81286-101-10) > 325 mL in 1 BOTTLE, PUMP2021-07-260000-00-00NoNoCurrent