Sunmitte Hand Sanitizer

Product NDC
75138-120
Requested package NDC
75138-120-10
11-digit product format
751380120
Labeler code
75138
Product ID
75138-120_a42dba05-4f0b-ace3-e053-2995a90abdbe
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Henan Shizheng Pharmaceutical Technology Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 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 packagepackage75138-12075138-120-10IInactivated 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 · 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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75138-120-06Sunmitte Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
75138-120-10Sunmitte Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
75138-120-30Sunmitte Hand Sanitizer300 mL in 1 BOTTLE, PUMPGEL3001
75138-120-50Sunmitte Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
75138-120-51Sunmitte Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
75138-120-52Sunmitte Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75138-120SUNMITTE HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [HENAN SHIZHENG PHARMACEUTICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 6 package rows20200428_a44fa866-b191-3373-e053-2a95a90a6344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa44fa866-b191-3373-e053-2a95a90a63441
1305100ethanol 0.75 ML/ML Topical GelSCDa44fa866-b191-3373-e053-2a95a90a63441
1305100ethanol 75 % Topical GelSYa44fa866-b191-3373-e053-2a95a90a63441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75138-120-1075138012010100 mL in 1 BOTTLE, PLASTIC (75138-120-10) 100 ml2020-03-300000-00-00NoNoCurrent