Home NDC 61619-717-28 Antisepation
Product NDC 61619-717
Requested package NDC 61619-717-28
11-digit product format 616190717
Labeler code 61619
Product ID 61619-717_d3d2f9a2-7dfb-745a-e053-2a95a90a6a3d
Type HUMAN OTC DRUG
Nonproprietary name Benzethonium Chloride
Dosage form LOTION
Route CUTANEOUS
Labeler A-Cute Derm, Incorporated
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-02-05
Marketing end 0000-00-00
Substance BENZETHONIUM CHLORIDE
Active strength 2 mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 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…
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 61619-717-07 Antisepation 29.6 mL in 1 BOTTLE, PLASTIC LOTION 29.6 8 61619-717-10 Antisepation 1 in 1 BOX LOTION 1 8 61619-717-12 Antisepation 946.4 mL in 1 BOTTLE, PLASTIC LOTION 946.4 8 61619-717-14 Antisepation 118.294 mL in 1 BOTTLE, PLASTIC LOTION 118.294 8 61619-717-18 Antisepation 236.6 mL in 1 BOTTLE, PLASTIC LOTION 236.6 8 61619-717-28 Antisepation 3800 mL in 1 BOTTLE, PLASTIC LOTION 3800 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZETHONIUM CHLORIDE ACTIVE INGREDIENT PH41D05744 ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 BENZETHONIUM ACTIVE MOIETY 1VU15B70BP ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 AMMONIUM LAURYL SULFATE INACTIVE INGREDIENT Q7AO2R1M0B ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE INACTIVE INGREDIENT 1EO3O1X7HG ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 LAURAMIDOPROPYL BETAINE INACTIVE INGREDIENT 23D6XVI233 ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 PEG-4 LAURATE INACTIVE INGREDIENT AYF4VM3N1Z ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61619-717 ANTISEPATION (BENZETHONIUM CHLORIDE) LOTION [A-CUTE DERM, INCORPORATED] 8 Legacy NDC, 6 package rows 20211224_0ef1322d-57e8-44be-a74d-a28dd9811c4e.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 61619-717-28 61619071728 3800 mL in 1 BOTTLE, PLASTIC (61619-717-28) 3800 ml 2016-02-05 0000-00-00 No No Current