Home NDC 78316-001-03 Gel Antibacterial Alcohol
Product NDC 78316-001
Requested package NDC 78316-001-03
11-digit product format 783160001
Labeler code 78316
Product ID 78316-001_a7e8235b-ff30-86af-e053-2a95a90a92d5
Type HUMAN OTC DRUG
Nonproprietary name Gel Antibacterial Aclohol
Dosage form GEL
Route TOPICAL
Labeler Sanchez, S.a. De C.v.
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-03-30
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 70 mL/70mL
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78316-001-01 Gel Antibacterial Alcohol 200000 mL in 1 BOTTLE, PLASTIC GEL 200000 1 78316-001-02 Gel Antibacterial Alcohol 1000 mL in 1 BOTTLE, PLASTIC GEL 1000 1 78316-001-03 Gel Antibacterial Alcohol 500 mL in 1 BOTTLE, PLASTIC GEL 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78316-001 GEL ANTIBACTERIAL ALCOHOL (GEL ANTIBACTERIAL ACLOHOL) GEL [SANCHEZ, S.A. DE C.V.] 1 Legacy NDC, 3 package rows 20200613_a7e82477-e1b7-2838-e053-2a95a90a7a79.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78316-001-03 78316000103 500 mL in 1 BOTTLE, PLASTIC (78316-001-03) 500 ml 2020-03-30 0000-00-00 No No Current