FDA.reportPublic FDA data

hand sanitizer

Product NDC
50049-100
Requested package NDC
50049-100-03
11-digit product format
500490100
Labeler code
50049
Product ID
50049-100_a3045a81-5251-6305-e053-2a95a90a2b61
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-21
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 packagepackage50049-10050049-100-03IInactivated by FDA2026-10-12

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#

NDC, Related label table
NDCRelated label
50049-100-0150049-100 Hand Sanitizer
50049-100-0250049-100 Hand Sanitizer
50049-100-0350049-100 Hand Sanitizer
50049-100-0450049-100 Hand Sanitizer
50049-100-0550049-100 Hand Sanitizer
50049-100-0650049-100 Hand Sanitizer
50049-100-0750049-100 Hand Sanitizer
50049-100-0850049-100 Hand Sanitizer
50049-100-0950049-100 Hand Sanitizer
50049-100-1050049-100 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50049-100-01hand sanitizer100 in 1 CARTONGEL1002
50049-100-01hand sanitizer45 mL in 1 BOTTLEGEL452
50049-100-02hand sanitizer75 mL in 1 BOTTLEGEL752
50049-100-02hand sanitizer60 in 1 CARTONGEL602
50049-100-03hand sanitizer24 in 1 CARTONGEL242
50049-100-03hand sanitizer187.5 mL in 1 BOTTLEGEL187.52
50049-100-04hand sanitizer375 mL in 1 BOTTLEGEL3752
50049-100-04hand sanitizer12 in 1 CARTONGEL122
50049-100-05hand sanitizer750 mL in 1 BOTTLEGEL7502
50049-100-05hand sanitizer6 in 1 CARTONGEL62
50049-100-06hand sanitizer2835 mL in 1 BOTTLEGEL28352
50049-100-06hand sanitizer4 in 1 CARTONGEL42
50049-100-07hand sanitizer4 in 1 CARTONGEL42
50049-100-07hand sanitizer3500 mL in 1 BOTTLEGEL35002
50049-100-08hand sanitizer112.5 mL in 1 BOTTLEGEL112.52
50049-100-08hand sanitizer24 in 1 CARTONGEL242
50049-100-09hand sanitizer24 in 1 CARTONGEL242
50049-100-09hand sanitizer135 mL in 1 BOTTLEGEL1352
50049-100-10hand sanitizer24 in 1 CARTONGEL242
50049-100-10hand sanitizer150 mL in 1 BOTTLEGEL1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50049-100HAND SANITIZER (ETHYL ALCOHOL) GEL [QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.]2Legacy NDC, 20 package rows20200412_a281d3cc-b0f4-81d1-e053-2995a90a5271.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa281d3cc-b0f4-81d1-e053-2995a90a52712
1305100ethanol 0.75 ML/ML Topical GelSCDa281d3cc-b0f4-81d1-e053-2995a90a52712
1305100ethanol 75 % Topical GelSYa281d3cc-b0f4-81d1-e053-2995a90a52712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50049-100-035004901000324 BOTTLE in 1 CARTON (50049-100-03) > 187.5 mL in 1 BOTTLE24 bottle2020-03-210000-00-00NoNoCurrent