Real Time Hand Sanitizer 70% Alcohol

Product NDC
58133-957
Requested package NDC
58133-957-04
11-digit product format
581330957
Labeler code
58133
Product ID
58133-957_aa5280a9-d306-7d6e-e053-2a95a90a44c3
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Cosmetic Specialty Labs, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-03
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58133-95758133-957-04IInactivated by FDA2026-09-14

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 · 15 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-957-03Real Time Hand Sanitizer 70% Alcohol89 mL in 1 BOTTLEGEL891
58133-957-04Real Time Hand Sanitizer 70% Alcohol118 mL in 1 BOTTLEGEL1181
58133-957-12Real Time Hand Sanitizer 70% Alcohol355 mL in 1 BOTTLEGEL3551
58133-957-15Real Time Hand Sanitizer 70% Alcohol44 mL in 1 BOTTLEGEL441
58133-957-16Real Time Hand Sanitizer 70% Alcohol474 mL in 1 BOTTLEGEL4741
58133-957-28Real Time Hand Sanitizer 70% Alcohol3789 mL in 1 BOTTLEGEL37891
58133-957-40Real Time Hand Sanitizer 70% Alcohol400 mL in 1 BOTTLEGEL4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-957REAL TIME HAND SANITIZER 70% ALCOHOL (ALCOHOL HAND SANITIZER) GEL [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 7 package rows20200714_aa529cba-8ded-11c6-e053-2995a90afe04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNaa529cba-8ded-11c6-e053-2995a90afe041
581662ethanol 0.7 ML/ML Topical GelSCDaa529cba-8ded-11c6-e053-2995a90afe041
581662ethanol 70 % Topical GelSYaa529cba-8ded-11c6-e053-2995a90afe041
581662ethyl alcohol 70 % Topical GelSYaa529cba-8ded-11c6-e053-2995a90afe041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58133-957-0458133095704118 mL in 1 BOTTLE (58133-957-04) 118 ml2020-07-130000-00-00NoNoCurrent