Home NDC 78604-646-37 CAL-SHINE ANTISEPTIC HAND SANITIZER
Product NDC 78604-646
Requested package NDC 78604-646-37
11-digit product format 786040646
Labeler code 78604
Product ID 78604-646_3f54e374-3eef-4e66-8d52-aace004432c5
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl alcohol
Dosage form LIQUID
Route TOPICAL
Labeler California Shine Construction
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-06-10
Marketing end 0000-00-00
Substance ISOPROPYL ALCOHOL
Active strength 75 mL/100mL
NDC exclude flag No
Listing certified through 2024-12-31
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 · 11 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78604-646-11 CAL-SHINE ANTISEPTIC HAND SANITIZER 118 mL in 1 BOTTLE LIQUID 118 4 78604-646-23 CAL-SHINE ANTISEPTIC HAND SANITIZER 237 mL in 1 BOTTLE LIQUID 237 4 78604-646-37 CAL-SHINE ANTISEPTIC HAND SANITIZER 3785 mL in 1 BOTTLE LIQUID 3785 4 78604-646-47 CAL-SHINE ANTISEPTIC HAND SANITIZER 474 mL in 1 BOTTLE LIQUID 474 4 78604-646-60 CAL-SHINE ANTISEPTIC HAND SANITIZER 60 mL in 1 BOTTLE LIQUID 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78604-646 CAL-SHINE ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [CALIFORNIA SHINE CONSTRUCTION] 4 Legacy NDC, 5 package rows 20230113_45489785-2228-4bf7-83c0-9160e357cffc.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 78604-646-37 78604064637 3785 mL in 1 BOTTLE (78604-646-37) 3785 ml 2020-06-10 0000-00-00 No No Current