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 28 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da93596-ec59-1e56-e063-6394a90afceb 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da951ff-37fe-4ca4-e063-6394a90a4baf 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da9cb12-3aaf-c0f9-e063-6394a90ae4a4 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da8a7b6-d147-87c3-e063-6394a90a784c 2026-03-22 Warnings Exact identifier application number: M003 ALCOHOL PREP AWABS ISOPROPYL ALCOHOL PATCH Henan Bingqing Yujie wipes Co., LTD 2e67e417-4dba-73a2-e063-6294a90aa4b2 2026-03-20 Warnings Exact identifier application number: M003 First Aid Antiseptic POVIDONE-IODINE Amazon.com Services LLC 3e2b255c-e3b7-468c-9ac1-b63279c5ac7f 2026-03-20 Warnings, Adverse reactions Exact identifier application number: M003 MediChoice OB Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. ed38fb97-b67d-430b-8f6b-4fc78c16aead 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE ISOPROPYL ALCOHOL Shield Line LLC f2177bd3-259d-4231-88b2-4a98e48e4df6 2026-03-17 Warnings Exact identifier application number: M003 MedPride 91% Rubbing Alcohol ISOPROPYL ALCOHOL Shield Line LLC e6ffe41e-efdc-0e0a-e053-2995a90a9e6a 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE with Wintergreen Oil ISOPROPYL ALCOHOL Shield Line LLC 57ac1a5c-758a-4422-8795-40391584434a 2026-03-17 Warnings Exact identifier application number: M003 NOVITA ISOPROPYL ALCOHOL 50% ISOPROPYL ALCOHOL Shield Line LLC 3ad79e91-377d-6587-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREEN ISOPROPYL ALCOHOL Shield Line LLC 3bd9fc61-b135-51f5-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 Walgreens Burn Gel Packettes BURN GEL PACKETTES Walgreens 3fa09045-d4c0-8119-e063-6394a90ab6a0 2026-03-17 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Pink Satin Prosecco ALCOHOL Scent Theory Products LLC 4d278204-9331-aeb8-e063-6394a90a87a4 2026-03-16 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Cherry Chai ALCOHOL Scent Theory Products LLC 4d27a964-6e91-27c0-e063-6294a90ad994 2026-03-16 Warnings Exact identifier application number: M003 HealthWise Advanced Hand Sanitizer with Lavender ETHYL ALCOHOL 70% Veridian Healthcare 4d144fb3-b4b7-135f-e063-6394a90a366e 2026-03-15 Warnings Exact identifier application number: M003 Biopure Alcohol Cotton Swabs ISOPROPYL ALCOHOL, COTTON SWAB QUEST USA CORP 3a60362b-b397-da15-e063-6394a90a45ff 2026-03-15 Warnings Exact identifier application number: M003 BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C) ANTIBACTERIAL HAND WIPE Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. a9318c76-7c41-1634-e053-2a95a90a6d44 2026-03-13 Warnings Exact identifier application number: M003 Iodine IODINE Nice-Pak Products, LLC 857f13fe-51c9-4e5b-b5e2-a981dedabf71 2026-03-12 Warnings, Adverse reactions Exact identifier application number: M003 Limited Edition Hand Sanitizer Cashmere Skin ALCOHOL Scent Theory Products LLC 4cdc4282-eb49-3120-e063-6294a90a2d61 2026-03-12 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