FDA.reportPublic FDA data

PurLif Tek

Product NDC
78994-002
Requested package NDC
78994-002-01
11-digit product format
789940002
Labeler code
78994
Product ID
78994-002_e443a011-58c4-2a04-e053-2995a90aec82
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
RFH BioTek Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage78994-00278994-002-01IInactivated by FDA2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
78994-002-012025-01-30PurLif Tek Hand sanitizer with Pure Silver
78994-002-022025-01-30PurLif Tek Hand sanitizer with Pure Silver
78994-002-012022-08-04PurLif Tek Hand sanitizer with Pure Silver
78994-002-022022-08-04PurLif Tek Hand sanitizer with Pure Silver
78994-002-012022-07-29PurLif Tek Hand sanitizer with Pure Silver
78994-002-022022-07-29PurLif Tek Hand sanitizer with Pure Silver

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78994-002-01PurLif Tek60 mL in 1 BOTTLE, PLASTICGEL604
78994-002-02PurLif Tek250 mL in 1 BOTTLE, PLASTICGEL2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78994-002PURLIF TEK (ALCOHOL) GEL [RFH BIOTEK INC.]4Legacy NDC, 2 package rows20220805_bc7f2911-4f63-468c-e053-2a95a90a6c41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNbc7f2911-4f63-468c-e053-2a95a90a6c414
581662ethanol 0.7 ML/ML Topical GelSCDbc7f2911-4f63-468c-e053-2a95a90a6c414
581662ethanol 70 % Topical GelSYbc7f2911-4f63-468c-e053-2a95a90a6c414
581662ethyl alcohol 70 % Topical GelSYbc7f2911-4f63-468c-e053-2a95a90a6c414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78994-002-017899400020160 mL in 1 BOTTLE, PLASTIC (78994-002-01) 60 ml2021-03-020000-00-00NoNoCurrent