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 61 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Hand Sanitizer Lakeshore Fresh ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 41533b69-05e7-d5f7-e063-6294a90a2d2b 2025-10-16 Warnings Exact identifier application number: M003 Meijer Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4153ac2a-e51c-f167-e063-6394a90a80d8 2025-10-16 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 412e961a-b7d4-b1c2-e063-6294a90a6b85 2025-10-15 Warnings Exact identifier application number: M003 equate First Aid Antiseptic POVIDONE-IODINE Walmart Inc. 43bbedec-be30-482a-8552-949b13d4bea1 2025-10-14 Warnings Exact identifier application number: M003 Tridergel BENZALKONIUM CHLORIDE Trifluent Pharma LLC f12d9e8c-1d69-49d9-a9e9-a392c681aa6c 2025-10-13 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe BENZOCAINE, ALCOHOL Total Resources International, Inc 5415073f-aa1d-4ed3-aa30-7470cd2efed1 2025-10-10 Warnings Exact identifier application number: M003 Lemyn Organics Medical-Grade Hand Sanitizer ALCOHOL Lemyn LLC b106289d-346a-74df-e053-2995a90aa426 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial Body Wash BENZALKONIUM CHLORIDE Spa de Soleil ab9dde33-1bd2-062f-e053-2a95a90a4d18 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial BENZALKONIUM CHLORIDE Spa de Soleil af89675e-e66f-0922-e053-2995a90ab9d2 2025-10-10 Warnings Exact identifier application number: M003 ANTISEPTIC WIPE 01 BENZALKONIUM CHLORIDE Total Resources International Inc. cf4a6a97-529e-7f11-e053-2a95a90a75a9 2025-10-10 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe ALCOHOL, LIDOCAINE HYDROCHLORIDE Total Resources International, Inc fff6f057-739e-40f1-8427-e1364c65af05 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Zhejiang Hudson Import& Export Co., Ltd 40b6c96c-e36f-6588-e063-6394a90adb46 2025-10-09 Warnings Exact identifier application number: M003 Curad ISOPROPYL ALCOHOL Medline Industries, LP c42de981-4e3f-1ac9-e053-2995a90aea98 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Avaria Health & Beauty Corp a3d87ef6-752b-b54b-e053-2a95a90af963 2025-10-08 Warnings Exact identifier application number: M003 Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic IODINE 2% Germa Products, LLC bf54254f-2ef3-102e-e053-2995a90ac083 2025-10-08 Warnings Exact identifier application number: M003 MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE O&M HALYARD, INC. 82a7710d-a9fa-4f68-8322-046a765ae929 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. 79d41cf0-301f-44d4-a76c-f4850c7ddce9 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL O&M HALYARD, INC. 8b84c8ed-040e-4c07-94cb-d5bdda744648 2025-10-08 Warnings Exact identifier application number: M003 MediChoice of Hydrogen Peroxide 3 10 Volume HYDROGEN PEROXIDE O&M HALYARD, INC. 34e77ef4-297d-4362-8f6e-abf80158b7f0 2025-10-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE O&M HALYARD, INC. 0ad5990a-a18d-4753-826b-6da313926698 2025-10-08 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