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 69 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povidone Iodine Prep POVIDONE IODINE Sion Biotext Medical Ltd e05af551-647d-4278-bb7f-86f888ddbb8b 2025-09-04 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. a8eedcfd-3b97-497a-9a34-d59b0dd78439 2025-09-03 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. 40cc6501-3cee-24cc-e054-00144ff88e88 2025-09-03 Warnings Exact identifier application number: M003 5OCT ANTIBACTERL HAND WIPES 5OCT ANTIBACTERL HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa 2025-09-01 Warnings Exact identifier application number: M003 AeroWipe STING RELIEF PAD Aero Healthcare US LLC 3d851c98-c9b9-f084-e063-6294a90acde2 2025-08-29 Warnings Exact identifier application number: M003 wet wipes 01 BENZALKONIUM CHLORIDE Cosmuses Cosmetics (Ningbo) Co., Ltd. 3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e 2025-08-25 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Brazilian Caramel Dreams ALCOHOL Scent Theory Products LLC 3d0d4ccf-ea31-cab2-e063-6294a90a4c69 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Sunset Samba ALCOHOL Scent Theory Products LLC 3d0d7d6b-33a0-5cd1-e063-6394a90ac8f6 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco Creme ALCOHOL Scent Theory Products LLC 3d0d7e73-8a83-9577-e063-6294a90aff6c 2025-08-23 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC fe439c60-5a02-648f-e053-6294a90a1403 2025-08-23 Warnings Exact identifier application number: M003 OP-First Aid Series ALCOHOL PREP PADS STERILE ISOPROPYL ALCOHOL CLOTH Yiwu Ori-Power Medtech Co.,Ltd. 351f4b1e-75c9-abec-e063-6294a90a2875 2025-08-22 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. 3cf2ff12-0220-3307-e063-6394a90abf08 2025-08-22 Warnings Exact identifier application number: M003 Chain Drug Marketing Association, Inc. ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc. 18fe4787-8986-4d64-e063-6394a90a3513 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Eucalyptus Aloe ALCOHOL Scent Theory Products LLC 3cf7e175-239d-e13b-e063-6294a90a7906 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Sunrise Glow ALCOHOL Scent Theory Products LLC 3cf7fce1-3112-0d66-e063-6294a90a9865 2025-08-22 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7d0e8-12b4-e410-e053-2a95a90a7f30 2025-08-21 Warnings Exact identifier application number: M003 American Red Cross 3 Hydrogen Peroxide HYDROGEN PEROXIDE MY IMPORTS USA LLC de46ffc7-3b66-dd8b-e053-2a95a90a28d8 2025-08-21 Warnings Exact identifier application number: M003 Antibacterial Hand wipes BENZALKONIUM CHLORIDE MY IMPORTS USA LLC 2ba77bab-7d02-d7c7-e063-6294a90aae87 2025-08-19 Warnings Exact identifier application number: M003 SANITIZING HAND WIPES SANITIZING HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3cb82a83-3067-80a6-e063-6394a90a8ab0 2025-08-19 Warnings Exact identifier application number: M003 MedPride PrepPads POVIDONE IODINE Shield Line LLC 289e92a2-f03f-4b8a-e054-00144ff8d46c 2025-08-19 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