FDA.reportPublic FDA data

SUBWAY ALCOHOL SANITIZER

Product NDC
78016-103
Requested package NDC
78016-103-16
11-digit product format
780160103
Labeler code
78016
Product ID
78016-103_d5d293aa-58d1-fec6-e053-2a95a90af4b8
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Klenlii Company
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage78016-10378016-103-16IInactivated by FDA2026-11-10

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
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage78016-10378016-103-16IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
78016-103-162024-05-09C16284748780-11030e365-5c2b-111a-e063-dadaa90a10e2KLENLII SUBWAY ALCOHOL SANITIZER GEL (62% ETHYL ALCOHOL) (78016-103)
78016-103-162024-01-30C16284748780-11030e365-5c2b-111a-e063-dadaa90a10e2KLENLII SUBWAY ALCOHOL SANITIZER GEL (62% ETHYL ALCOHOL) (78016-103)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-103-16SUBWAY ALCOHOL SANITIZER473 mL in 1 BOTTLEGEL4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-103SUBWAY ALCOHOL SANITIZER (ETHYL ALCOHOL) GEL [KLENLII COMPANY]4Legacy NDC, 1 package rows20240511_45794deb-194c-4473-8e1c-811244663509.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN45794deb-194c-4473-8e1c-8112446635094
581660ethanol 0.62 ML/ML Topical GelSCD45794deb-194c-4473-8e1c-8112446635094
581660ethanol 62 % Topical GelSY45794deb-194c-4473-8e1c-8112446635094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78016-103-1678016010316473 mL in 1 BOTTLE (78016-103-16) 473 ml2020-06-100000-00-00NoNoCurrent