Home NDC 78643-110-04 Serene Clean and Pure Hand Sanitizer Gel
Product NDC 78643-110
Requested package NDC 78643-110-04
11-digit product format 786430110
Labeler code 78643
Product ID 78643-110_aa98e90a-483d-5095-e053-2a95a90af772
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Serene Clean & Pure LLC
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-06-08
Marketing end 0000-00-00
Substance ISOPROPYL ALCOHOL
Active strength 75 mL/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78643-110-01 Serene Clean and Pure Hand Sanitizer Gel 3785.41 mL in 1 BOTTLE, PLASTIC GEL 3785.41 2 78643-110-02 Serene Clean and Pure Hand Sanitizer Gel 59 mL in 1 BOTTLE, PLASTIC GEL 59 2 78643-110-04 Serene Clean and Pure Hand Sanitizer Gel 118 mL in 1 BOTTLE, PLASTIC GEL 118 2 78643-110-08 Serene Clean and Pure Hand Sanitizer Gel 236 mL in 1 BOTTLE, PLASTIC GEL 236 2 78643-110-10 Serene Clean and Pure Hand Sanitizer Gel 296 mL in 1 BOTTLE, PLASTIC GEL 296 2 78643-110-16 Serene Clean and Pure Hand Sanitizer Gel 296 mL in 1 BOTTLE, PLASTIC GEL 296 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78643-110 SERENE CLEAN AND PURE HAND SANITIZER GEL (ISOPROPYL ALCOHOL) GEL [SERENE CLEAN & PURE LLC] 2 Legacy NDC, 6 package rows 20200717_a7c26a66-05ad-0fae-e053-2a95a90ad3cf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78643-110-04 78643011004 118 mL in 1 BOTTLE, PLASTIC (78643-110-04) 118 ml 2020-06-08 0000-00-00 No No Current