Home NDC 67618-183 Maximum Strength Betadine Clear
Product NDC 67618-183
11-digit product format 676180183
Labeler code 67618
Product ID 67618-183_074e0e6b-8391-4541-b628-bd74a5e7c29c
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Cl and Pramoxine HCl
Dosage form SPRAY
Route TOPICAL
Labeler Atlantis Consumer Healthcare, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-22
Substance BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength .13; 1 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Maximum Strength Betadine Clear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 mg/mL PRAMOXINE HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67618-183-06 Maximum Strength Betadine Clear 177 mL in 1 BOTTLE SPRAY 177 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67618-183 MAXIMUM STRENGTH BETADINE CLEAR (BENZALKONIUM CL AND PRAMOXINE HCL) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.] 1 Current NDC, 1 package rows 20240111_31b94a76-1536-47c0-ab03-e487c2625c58.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 24 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Scriptsusa Hand Sanitizer ALCOHOL Energized Solution Corp 4f97edd9-717a-315b-e063-6394a90aade7 2026-04-27 Warnings Exact identifier application number: M003 Tigerherbs Natural Healing Cream BEDSORE CREAM Shenzhen Yao Yu Technology Co., LTD 392c3666-b86e-9266-e063-6394a90ae502 2026-04-25 Warnings Exact identifier application number: M003 MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 5006097e-16e6-d180-e063-6394a90ae0c2 2026-04-22 Warnings Exact identifier application number: M003 Sanitizing Wipes Lavender ALCOHOL The Honest Company Inc. 4a69b1d5-81ad-2cd1-e063-6294a90ac62d 2026-04-22 Warnings Exact identifier application number: M003 Sanitizing Wipes Grapefruit ALCOHOL The Honest Company Inc. 4aa8c899-e5c3-9eec-e063-6294a90a6eae 2026-04-22 Warnings Exact identifier application number: M003 3M Skin and Nasal Antiseptic POVIDONE-IODINE Solventum US LLC 1a94494d-7dd3-4f32-bc42-81c199fe233e 2026-04-22 Warnings Exact identifier application number: M003 3M Avagard D ALCOHOL Solventum US LLC 220c8a49-2a52-4660-8ad4-de553bd03226 2026-04-22 Warnings Exact identifier application number: M003 Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry Crumble ALCOHOL SPRAY Scent Theory Products LLC 4ffa6e26-870f-586e-e063-6394a90ad975 2026-04-21 Warnings Exact identifier application number: M003 BIOPURE 50CT ANTI BACTERIAL HAND WIPES BENZALKONIUM CHLORIDE Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. 4fcf2c05-9bd2-2813-e063-6294a90a4401 2026-04-19 Warnings Exact identifier application number: M003 Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose) ALCOHOL SPRAY Scent Theory Products LLC 4fc170dd-7c6b-b810-e063-6394a90ae61f 2026-04-18 Warnings Exact identifier application number: M003 Megababe - Squeaky Clean Hand Sanitizer ETHYL ALCOHOL MEGABABE, LLC 249e00ef-fe9d-dc07-e063-6394a90a9f4c 2026-04-16 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Prostat First Aid 4f9adbac-5497-e7be-e063-6294a90a7518 2026-04-16 Warnings Exact identifier application number: M003 Megababe - Squeaky Clean Hand Sanitizer ETHYL ALCOHOL MEGABABE, LLC 2d940d35-6a73-e494-e063-6394a90a9d16 2026-04-14 Warnings Exact identifier application number: M003 Freskaro Povidone Iodine POVIDONE IODINE 10% Pharma Nobis, LLC 4f711d3b-5ed6-5dd4-e063-6294a90afeaa 2026-04-14 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Perrigo Direct, Inc ec43a3f5-c5f3-439b-8764-ca92fefb45c9 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Walmart Inc. ebd02cd3-75cc-444b-8284-d28733a2855b 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL MSC Industrial Supply b248ad4a-ed92-4d03-b0da-9639c46e1949 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M003 Smart Care Hand Sanitizer Sunset Guava ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4f01fc3a-5b01-4b6b-e063-6294a90aefb4 2026-04-09 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Fresh Rain ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4f02adaa-1440-5778-e063-6294a90a344a 2026-04-09 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon Wave ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4f031f62-e56c-9063-e063-6394a90af9c1 2026-04-09 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67618-183-06 67618018306 177 mL in 1 BOTTLE (67618-183-06) 177 ml 2023-12-22 No No Current