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 75 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Hand Sanitizer - Sweet Citrus ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38863865-9361-fd1a-e063-6394a90a84f4 2025-06-26 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Squishmallows Patty ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38613f78-8480-637d-e063-6394a90a4ef3 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Barbie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38626ced-5644-9f82-e063-6294a90ac7a1 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Pistachio Brule ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38715507-d881-d8b3-e063-6394a90ad348 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Juicy Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3871ec77-de30-0c89-e063-6394a90a9e7a 2025-06-25 Warnings Exact identifier application number: M003 Meijer Hydrating Power Mist Hand Sanitizer- Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 384c26c8-7f2d-8c3a-e063-6394a90aa908 2025-06-24 Warnings Exact identifier application number: M003 Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser ISOPROPYL ALCOHOL Amerisouce Bergen fc28cf11-afb9-4295-bee3-735ab10f6bbc 2025-06-24 Warnings Exact identifier application number: M003 Meret Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 385def83-38fe-df7f-e063-6394a90abbf0 2025-06-24 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 38381a41-db33-45c6-e063-6394a90a2317 2025-06-23 Warnings Exact identifier application number: M003 Benzethonium chloride Plus Dyclonine hydrochloride LIQUID BANDAGE Rite Aid Corporation 1069226f-dfd0-4028-a033-30fa4b1e835e 2025-06-21 Warnings Exact identifier application number: M003 Cart Wipes Clean Sanitizing Wipes BENZALKONIUM CHLORIDE Carts and Parts INC. 6a8433e8-7b96-44ce-b8e2-c60575898dab 2025-06-18 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 99% ISOPROPYL ALCOHOL LJ Pharma a06953d7-d685-45ac-b1c6-e66dc7a05bca 2025-06-18 Warnings Exact identifier application number: M003 Sweet Orange Bergamot and Aloe ETHYL ALCOHOL ALO New York LLC 31cecf1e-1d6b-0033-e063-6294a90a7b8e 2025-06-18 Warnings Exact identifier application number: M003 POVIDONE-IODINE POVIDONE-IODINE Acme United Corporation 37c709ae-ef37-0b46-e063-6394a90af861 2025-06-17 Warnings Exact identifier application number: M003 Universal 70% Rubbing Alcohol with Wintergreen and Glycerin ISOPROPYL ALCOHOL Universal Distribution Center LLC 1fdff866-f534-4c16-b755-b2efd1e6e837 2025-06-17 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 99% WINTERGREEN ISOPROPYL ALCOHOL LJ Pharma de7b2253-7f36-4a27-8838-442ec635f69b 2025-06-16 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 70% WINTERGREEN ISOPROPYL ALCOHOL LJ Pharma 98ebf7a7-7c13-4feb-90b5-21cc6dab99f6 2025-06-16 Warnings Exact identifier application number: M003 Lacura Moisturizing Hand Sanitizer ETHYL ALCOHOL 62% Aldi dafa52fe-42e6-2c21-e053-2995a90a413f 2025-06-13 Warnings Exact identifier application number: M003 Refresher ALCOHOL Jao Limited 1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f8 2025-06-13 Warnings Exact identifier application number: M003 Povidone Iodine Prep POVIDONE IODINE Sion Biotext Medical Ltd 34769116-2520-f862-e063-6394a90a5949 2025-06-11 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