FDA.reportPublic FDA data

hand sanitizer

Product NDC
50049-103
11-digit product format
500490103
Labeler code
50049
Product ID
50049-103_a371b19e-645a-43a2-e053-2995a90afdd4
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50049-103IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-01IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-02IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-03IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-04IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-05IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-06IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-07IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-08IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-09IInactivated by FDA2026-10-12
excluded packagepackage50049-10350049-103-10IInactivated 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 4 · 198 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50049-103-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50049-103-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50049-103-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50049-103-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50049-103-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50049-103-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50049-103-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50049-103-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50049-103-05cdf11ea48f46…ba0047e9e063…

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
50049-103-0150049-103 Hand Sanitizer
50049-103-0250049-103 Hand Sanitizer
50049-103-0350049-103 Hand Sanitizer
50049-103-0450049-103 Hand Sanitizer
50049-103-0550049-103 Hand Sanitizer
50049-103-0650049-103 Hand Sanitizer
50049-103-0750049-103 Hand Sanitizer
50049-103-0850049-103 Hand Sanitizer
50049-103-0950049-103 Hand Sanitizer
50049-103-1050049-103 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50049-103-01hand sanitizer22.5 mL in 1 BOTTLEGEL22.51
50049-103-01hand sanitizer100 in 1 CARTONGEL1001
50049-103-02hand sanitizer100 in 1 CARTONGEL1001
50049-103-02hand sanitizer45 mL in 1 BOTTLEGEL451
50049-103-03hand sanitizer75 mL in 1 BOTTLEGEL751
50049-103-03hand sanitizer60 in 1 CARTONGEL601
50049-103-04hand sanitizer24 in 1 CARTONGEL241
50049-103-04hand sanitizer187.5 mL in 1 BOTTLEGEL187.51
50049-103-05hand sanitizer375 mL in 1 BOTTLEGEL3751
50049-103-05hand sanitizer12 in 1 CARTONGEL121
50049-103-06hand sanitizer750 mL in 1 BOTTLEGEL7501
50049-103-06hand sanitizer6 in 1 CARTONGEL61
50049-103-07hand sanitizer4 in 1 CARTONGEL41
50049-103-07hand sanitizer2835 mL in 1 BOTTLEGEL28351
50049-103-08hand sanitizer3750 mL in 1 BOTTLEGEL37501
50049-103-08hand sanitizer4 in 1 CARTONGEL41
50049-103-09hand sanitizer135 mL in 1 BOTTLEGEL1351
50049-103-09hand sanitizer24 in 1 CARTONGEL241
50049-103-10hand sanitizer24 in 1 CARTONGEL241
50049-103-10hand sanitizer177.75 mL in 1 BOTTLEGEL177.751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50049-103HAND SANITIZER (ETHYL ALCOHOL) GEL [QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.]1Legacy NDC, 20 package rows20200417_a371b29d-1461-11c7-e053-2a95a90a37b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa371b29d-1461-11c7-e053-2a95a90a37b41
1305100ethanol 0.75 ML/ML Topical GelSCDa371b29d-1461-11c7-e053-2a95a90a37b41
1305100ethanol 75 % Topical GelSYa371b29d-1461-11c7-e053-2a95a90a37b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50049-103-0150049010301100 BOTTLE in 1 CARTON (50049-103-01) > 22.5 mL in 1 BOTTLE100 bottle2020-03-210000-00-00NoNoCurrent
50049-103-0250049010302100 BOTTLE in 1 CARTON (50049-103-02) > 45 mL in 1 BOTTLE100 bottle2020-03-210000-00-00NoNoCurrent
50049-103-035004901030360 BOTTLE in 1 CARTON (50049-103-03) > 75 mL in 1 BOTTLE60 bottle2020-03-210000-00-00NoNoCurrent
50049-103-045004901030424 BOTTLE in 1 CARTON (50049-103-04) > 187.5 mL in 1 BOTTLE24 bottle2020-03-210000-00-00NoNoCurrent
50049-103-055004901030512 BOTTLE in 1 CARTON (50049-103-05) > 375 mL in 1 BOTTLE12 bottle2020-03-210000-00-00NoNoCurrent
50049-103-06500490103066 BOTTLE in 1 CARTON (50049-103-06) > 750 mL in 1 BOTTLE6 bottle2020-03-210000-00-00NoNoCurrent
50049-103-07500490103074 BOTTLE in 1 CARTON (50049-103-07) > 2835 mL in 1 BOTTLE4 bottle2020-03-210000-00-00NoNoCurrent
50049-103-08500490103084 BOTTLE in 1 CARTON (50049-103-08) > 3750 mL in 1 BOTTLE4 bottle2020-03-210000-00-00NoNoCurrent
50049-103-095004901030924 BOTTLE in 1 CARTON (50049-103-09) > 135 mL in 1 BOTTLE24 bottle2020-03-210000-00-00NoNoCurrent
50049-103-105004901031024 BOTTLE in 1 CARTON (50049-103-10) > 177.75 mL in 1 BOTTLE24 bottle2020-03-210000-00-00NoNoCurrent