FDA.reportPublic FDA data

SaniHoo Gel Hand Sanitizer

Product NDC
78888-380
Requested package NDC
78888-380-55
11-digit product format
788880380
Labeler code
78888
Product ID
78888-380_a9fa8588-c508-0e1b-e053-2995a90a9ff5
Type
HUMAN OTC DRUG
Nonproprietary name
Gel Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Red Barn Brands, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-26
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
69 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 packagepackage78888-38078888-380-55IInactivated 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, Indexing SPL, Related label table
NDCIndexing SPLRelated label
78888-380-01d6a99b39-4231-a426-e053-dadaa90af4c2a9fa10bc-5685-2e88-e053-2a95a90a20cd
78888-380-04d6a99b39-ab0a-a426-e053-dadaa90af4c2a9003651-92c4-762c-e053-2995a90ab95d
78888-380-16d6a99b39-f75c-a426-e053-dadaa90af4c2a9fa4af7-a244-4c65-e053-2a95a90ad043
78888-380-27d6a99b39-b670-a426-e053-dadaa90af4c2a9fa10bc-5684-2e88-e053-2a95a90a20cd
78888-380-32d6a99b39-f759-a426-e053-dadaa90af4c2a9fa4921-cd92-0e98-e053-2a95a90aa066
78888-380-55d6a99b39-f75f-a426-e053-dadaa90af4c2a9fa859c-37ca-0dc6-e053-2995a90aede5
78888-380-64d6a99b39-ab1c-a426-e053-dadaa90af4c2a9fa4946-c3c3-7163-e053-2995a90a4212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78888-380-01SaniHoo Gel Hand Sanitizer3785.41 mL in 1 BOTTLEGEL3785.414
78888-380-27SaniHoo Gel Hand Sanitizer1040987.75 mL in 1 BOTTLEGEL1040987.754
78888-380-55SaniHoo Gel Hand Sanitizer208198 mL in 1 BOTTLEGEL2081984
78888-380-16SaniHoo Gel Hand Sanitizer473.176 mL in 1 BOTTLEGEL473.1763
78888-380-32SaniHoo Gel Hand Sanitizer946.353 mL in 1 BOTTLEGEL946.3533
78888-380-64SaniHoo Gel Hand Sanitizer1892.71 mL in 1 BOTTLEGEL1892.713
78888-380-04SaniHoo Gel Hand Sanitizer118.294 mL in 1 BOTTLEGEL118.2942

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]4Legacy NDC, 1 package rows20200709_a9fa859c-37ca-0dc6-e053-2995a90aede5.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]4Legacy NDC, 1 package rows20200709_a9fa10bc-5684-2e88-e053-2a95a90a20cd.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]4Legacy NDC, 1 package rows20200709_a9fa10bc-5685-2e88-e053-2a95a90a20cd.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]3Legacy NDC, 1 package rows20200709_a9fa4946-c3c3-7163-e053-2995a90a4212.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]3Legacy NDC, 1 package rows20200709_a9fa4921-cd92-0e98-e053-2a95a90aa066.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]3Legacy NDC, 1 package rows20200709_a9fa4af7-a244-4c65-e053-2a95a90ad043.zip
78888-380SANIHOO GEL HAND SANITIZER (GEL HAND SANITIZER) GEL [RED BARN BRANDS, LLC]2Legacy NDC, 1 package rows20200709_a9003651-92c4-762c-e053-2995a90ab95d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287763ethanol 69 % Topical GelPSNa9fa859c-37ca-0dc6-e053-2995a90aede54
2287763ethanol 69 % Topical GelPSNa9fa10bc-5685-2e88-e053-2a95a90a20cd4
2287763ethanol 69 % Topical GelPSNa9fa10bc-5684-2e88-e053-2a95a90a20cd4
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa859c-37ca-0dc6-e053-2995a90aede54
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa10bc-5685-2e88-e053-2a95a90a20cd4
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa10bc-5684-2e88-e053-2a95a90a20cd4
2287763ethanol 69 % Topical GelSYa9fa10bc-5684-2e88-e053-2a95a90a20cd4
2287763ethanol 69 % Topical GelSYa9fa10bc-5685-2e88-e053-2a95a90a20cd4
2287763ethanol 69 % Topical GelSYa9fa859c-37ca-0dc6-e053-2995a90aede54
2287763ethanol 69 % Topical GelPSNa9fa4921-cd92-0e98-e053-2a95a90aa0663
2287763ethanol 69 % Topical GelPSNa9fa4946-c3c3-7163-e053-2995a90a42123
2287763ethanol 69 % Topical GelPSNa9fa4af7-a244-4c65-e053-2a95a90ad0433
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa4921-cd92-0e98-e053-2a95a90aa0663
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa4946-c3c3-7163-e053-2995a90a42123
2287763ethanol 0.69 ML/ML Topical GelSCDa9fa4af7-a244-4c65-e053-2a95a90ad0433
2287763ethanol 69 % Topical GelSYa9fa4921-cd92-0e98-e053-2a95a90aa0663
2287763ethanol 69 % Topical GelSYa9fa4af7-a244-4c65-e053-2a95a90ad0433
2287763ethanol 69 % Topical GelSYa9fa4946-c3c3-7163-e053-2995a90a42123
2287763ethanol 69 % Topical GelPSNa9003651-92c4-762c-e053-2995a90ab95d2
2287763ethanol 0.69 ML/ML Topical GelSCDa9003651-92c4-762c-e053-2995a90ab95d2
2287763ethanol 69 % Topical GelSYa9003651-92c4-762c-e053-2995a90ab95d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78888-380-5578888038055208198 mL in 1 BOTTLE (78888-380-55) 208198 ml2020-06-260000-00-00NoNoCurrent