FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
50049-002
Requested package NDC
50049-002-04
11-digit product format
500490002
Labeler code
50049
Product ID
50049-002_a52d438f-befc-abd9-e053-2a95a90a605b
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
2020-05-08
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 packagepackage50049-00250049-002-04IInactivated 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#

NDC, Related label table
NDCRelated label
50049-002-0150049-002 Hand Sanitizer
50049-002-0250049-002 Hand Sanitizer
50049-002-0350049-002 Hand Sanitizer
50049-002-0450049-002 Hand Sanitizer
50049-002-0550049-002 Hand Sanitizer
50049-002-0650049-002 Hand Sanitizer
50049-002-0750049-002 Hand Sanitizer
50049-002-0850049-002 Hand Sanitizer
50049-002-0950049-002 Hand Sanitizer
50049-002-1050049-002 Hand Sanitizer
50049-002-1150049-002 Hand Sanitizer
50049-002-1250049-002 Hand Sanitizer
50049-002-1350049-002 Hand Sanitizer
50049-002-1450049-002 Hand Sanitizer
50049-002-1550049-002 Hand Sanitizer
50049-002-1650049-002 Hand Sanitizer
50049-002-1750049-002 Hand Sanitizer
50049-002-1850049-002 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50049-002-01Hand Sanitizer45 mL in 1 BOTTLEGEL451
50049-002-01Hand Sanitizer150 in 1 CARTONGEL1501
50049-002-02Hand Sanitizer100 in 1 CARTONGEL1001
50049-002-02Hand Sanitizer75 mL in 1 BOTTLEGEL751
50049-002-03Hand Sanitizer24 in 1 CARTONGEL241
50049-002-03Hand Sanitizer187.5 mL in 1 BOTTLEGEL187.51
50049-002-04Hand Sanitizer20 in 1 CARTONGEL201
50049-002-04Hand Sanitizer375 mL in 1 BOTTLEGEL3751
50049-002-05Hand Sanitizer750 mL in 1 BOTTLEGEL7501
50049-002-05Hand Sanitizer18 in 1 CARTONGEL181
50049-002-06Hand Sanitizer200 in 1 CARTONGEL2001
50049-002-06Hand Sanitizer22.5 mL in 1 BOTTLEGEL22.51
50049-002-07Hand Sanitizer37.5 mL in 1 BOTTLEGEL37.51
50049-002-07Hand Sanitizer150 in 1 CARTONGEL1501
50049-002-08Hand Sanitizer24 in 1 CARTONGEL241
50049-002-08Hand Sanitizer112.5 mL in 1 BOTTLEGEL112.51
50049-002-09Hand Sanitizer135 mL in 1 BOTTLEGEL1351
50049-002-09Hand Sanitizer24 in 1 CARTONGEL241
50049-002-10Hand Sanitizer24 in 1 CARTONGEL241
50049-002-10Hand Sanitizer150 mL in 1 BOTTLEGEL1501
50049-002-11Hand Sanitizer225 mL in 1 BOTTLEGEL2251
50049-002-11Hand Sanitizer24 in 1 CARTONGEL241
50049-002-12Hand Sanitizer367.5 mL in 1 BOTTLEGEL367.51
50049-002-12Hand Sanitizer24 in 1 CARTONGEL241
50049-002-13Hand Sanitizer900 mL in 1 BOTTLEGEL9001
50049-002-13Hand Sanitizer12 in 1 CARTONGEL121
50049-002-14Hand Sanitizer12 in 1 CARTONGEL121
50049-002-14Hand Sanitizer1500 mL in 1 BOTTLEGEL15001
50049-002-15Hand Sanitizer4 in 1 CARTONGEL41
50049-002-15Hand Sanitizer2835 mL in 1 BOTTLEGEL28351
50049-002-16Hand Sanitizer3750 mL in 1 BOTTLEGEL37501
50049-002-16Hand Sanitizer4 in 1 CARTONGEL41
50049-002-17Hand Sanitizer2 in 1 CARTONGEL21
50049-002-17Hand Sanitizer7500 mL in 1 BOTTLEGEL75001
50049-002-18Hand Sanitizer18750 mL in 1 BOTTLEGEL187501
50049-002-18Hand Sanitizer1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50049-002HAND SANITIZER (ETHYL ALCOHOL) GEL [QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO., LTD.]1Legacy NDC, 36 package rows20200509_a52d438f-befb-abd9-e053-2a95a90a605b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa52d438f-befb-abd9-e053-2a95a90a605b1
1305100ethanol 0.75 ML/ML Topical GelSCDa52d438f-befb-abd9-e053-2a95a90a605b1
1305100ethanol 75 % Topical GelSYa52d438f-befb-abd9-e053-2a95a90a605b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50049-002-045004900020420 BOTTLE in 1 CARTON (50049-002-04) > 375 mL in 1 BOTTLE20 bottle2020-05-090000-00-00NoNoCurrent