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 113 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 1c7f9a00-6600-4b0d-af11-fa776b22e678 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 1c9f2c8b-6ed6-4e54-a151-5be4acb290e4 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 878bfaa7-d553-40db-8311-19010930abd9 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd c1273e40-5c09-435b-adf3-e352fdd01e9e 2023-10-23 Warnings Exact identifier application number: M003 POVIDONE IODINE SCRUB SWABSTICK 3s POVIDONE-IODINE Jianerkang Medical Co., Ltd 65783da9-acca-41c7-860b-1de108edc583 2023-10-23 Warnings Exact identifier application number: M003 Obstetrical Towelette BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 8db4eb14-85b6-4c8e-9623-39a43b3827a1 2023-10-23 Warnings Exact identifier application number: M003 POVIDONE IODINE PREP PAD Sterile POVIDONE-IODINE Jianerkang Medical Co., Ltd ac3aa401-a124-4eb7-9598-119be0f24ddd 2023-10-23 Warnings Exact identifier application number: M003 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd c13af96e-f76a-4577-8d57-811ccc652738 2023-10-23 Warnings Exact identifier application number: M003 Povidone-Iodine Prep Pad POVIDONE-IODINE Cardinal Health 200, Inc. 06c8a6f6-2fc8-4292-a3b5-6311a918a521 2023-10-23 Warnings Exact identifier application number: M003 Antiseptic BZK Towelette BENZALKONIUM CHLORIDE Cardinal Health 200, Inc. 8dd79ffe-f742-438c-9814-612f900ad6a9 2023-10-23 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd f231a572-a99d-4146-afa3-e73ea1cee027 2023-10-22 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd 42778607-6170-4a5e-94d0-5e6cd064eec6 2023-10-22 Warnings Exact identifier application number: M003 Alcohol ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 76048b01-28f3-4e43-9da9-974b2b511a10 2023-10-22 Warnings Exact identifier application number: M003 GENUINE FIRST AID Antiseptic Hand Sanitizer ETHYL ALCOHOL Nantong Health & Beyond Hygienic Products Inc. d25f02f1-268c-44d8-9a55-c6efcbe8eed1 2023-10-19 Warnings Exact identifier application number: M003 Brompton and Langley Moisturizing Hand Sanitizer Lavnder Vanilla ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 90bd3436-a8bc-4c19-a300-d59236a8de27 2023-10-19 Warnings Exact identifier application number: M003 Up and Up 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Target Corporation becc8fe3-eaf5-4429-b462-a87dd09c4db8 2023-10-17 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 766ad4df-2100-4f26-bd8b-5c5a0918698e 2023-10-13 Warnings Exact identifier application number: M003 GoodSense Alcohol Swabs ISOPROPYL ALCOHOL Geiss, Destin and Dunn 968bab9f-5b74-270b-e053-2995a90a0df4 2023-10-13 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 5854f241-6cfc-4e5a-ba72-92dd0703f728 2023-10-13 Warnings Exact identifier application number: M003 DawnMist Alcohol Hand Sanitizer ALCOHOL Dukal LLC a2df96a9-8514-6839-e053-2a95a90a9417 2023-10-13 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