FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
75772-422
Requested package NDC
75772-422-03
11-digit product format
757720422
Labeler code
75772
Product ID
75772-422_a70ca64e-6298-75a1-e053-2995a90a1535
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Bio Systems de Mexico SA de CV
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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 packagepackage75772-42275772-422-03IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75772-422-022022-01-28C16284748780-1d6a99b39-8b84-a426-e053-dadaa90af4c2a52764a0-f573-517d-e053-2a95a90a9a9d
75772-422-032022-01-28C16284748780-1d6a99b39-a826-a426-e053-dadaa90af4c2a52b761e-0d2e-8baf-e053-2a95a90a4ccc
75772-422-052022-01-28C16284748780-1d6a99b39-71a3-a426-e053-dadaa90af4c2a52908ea-9d2a-3e12-e053-2a95a90a2045

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75772-422-03Hand Sanitizer260 mL in 1 BOTTLEGEL2602
75772-422-02Hand Sanitizer270 mL in 1 BOTTLEGEL2701
75772-422-05Hand Sanitizer520 mL in 1 BOTTLEGEL5201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75772-422HAND SANITIZER (ALCOHOL) GEL [BIO SYSTEMS DE MEXICO SA DE CV]2Legacy NDC, 1 package rows20200602_a52b761e-0d2e-8baf-e053-2a95a90a4ccc.zip
75772-422HAND SANITIZER (ALCOHOL) GEL [BIO SYSTEM DE MEXICO SA DE CV]1Legacy NDC, 1 package rows20200509_a52908ea-9d2a-3e12-e053-2a95a90a2045.zip
75772-422HAND SANITIZER (ALCOHOL) GEL [BIO SYSTEM DE MEXICO SA DE CV]1Legacy NDC, 1 package rows20200509_a52764a0-f573-517d-e053-2a95a90a9a9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa52b761e-0d2e-8baf-e053-2a95a90a4ccc2
581662ethanol 0.7 ML/ML Topical GelSCDa52b761e-0d2e-8baf-e053-2a95a90a4ccc2
581662ethanol 70 % Topical GelSYa52b761e-0d2e-8baf-e053-2a95a90a4ccc2
581662ethyl alcohol 70 % Topical GelSYa52b761e-0d2e-8baf-e053-2a95a90a4ccc2
581662ethanol 70 % Topical GelPSNa52764a0-f573-517d-e053-2a95a90a9a9d1
581662ethanol 70 % Topical GelPSNa52908ea-9d2a-3e12-e053-2a95a90a20451
581662ethanol 0.7 ML/ML Topical GelSCDa52764a0-f573-517d-e053-2a95a90a9a9d1
581662ethanol 0.7 ML/ML Topical GelSCDa52908ea-9d2a-3e12-e053-2a95a90a20451
581662ethanol 70 % Topical GelSYa52764a0-f573-517d-e053-2a95a90a9a9d1
581662ethanol 70 % Topical GelSYa52908ea-9d2a-3e12-e053-2a95a90a20451
581662ethyl alcohol 70 % Topical GelSYa52764a0-f573-517d-e053-2a95a90a9a9d1
581662ethyl alcohol 70 % Topical GelSYa52908ea-9d2a-3e12-e053-2a95a90a20451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75772-422-0375772042203260 mL in 1 BOTTLE (75772-422-03) 260 ml2020-03-300000-00-00NoNoCurrent