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 48 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freshnap Plus - 80% Ethyl Alcohol Towelette ALCOHOL TOWELETTE KARI-OUT LLC f4ae66e3-323b-5e2e-e053-2995a90acf42 2025-12-27 Warnings Exact identifier application number: M003 Guardelle BENZALKONIUM CHLORIDE Social Medical Supply LLC 8793e3be-7409-4f71-9397-abbeacd27cf8 2025-12-22 Warnings Exact identifier application number: M003 CareALL First Aid Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCL New World Imports, Inc 69eef888-0044-485c-96a1-247ed1204858 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Pear Blossom Tea ALCOHOL SOLUTION Noshinku 46927edb-f8be-f0b9-e063-6294a90a8e56 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Santal Blanc ALCOHOL SOLUTION Noshinku 4692c807-268e-6477-e063-6394a90aac0a 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Vanilla Creme ALCOHOL SOLUTION Noshinku 4692e68c-2bc8-83f8-e063-6294a90a84e4 2025-12-22 Warnings Exact identifier application number: M003 Alcohol sanitizer wipes ALCOHOL/PURIFIED WATER SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. ab9634bd-4226-2f73-e053-2995a90a802f 2025-12-19 Warnings Exact identifier application number: M003 Sanitizing Wipes BENZALKONIUM CHLORIDE Wipes LLC 9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3 2025-12-19 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 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