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 1 of 117 · 2,333 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC e9a9fc7c-31da-ea3f-e053-2a95a90a0eab 2026-09-09 Warnings Exact identifier application number: M003 Alcohol Prep Pad Medium ALCOHOL PREP PAD Yangzhou Huanrui Medical Technology Co., Ltd 5af3eedc-d01e-c9e9-e063-6394a90a49e1 2026-09-08 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Prep Pad POVIDONE-IODINE Henry Schein, Inc. 313416b8-60b2-4a77-9b56-5c507aae9072 2026-09-08 Warnings Exact identifier application number: M003 Verifine ALCOHOL SWABS Promisemed Hangzhou Meditech Co., LTD 5af9f31b-0c92-e3a9-e063-6394a90a38c9 2026-09-08 Warnings Exact identifier application number: M003 Verifine ALCOHOL SWABS Promisemed Hangzhou Meditech Co., LTD 5afc0201-490e-ccf3-e063-6394a90aadad 2026-09-08 Warnings Exact identifier application number: M003 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL CLOTH JINHUA JINGDI MEDICAL SUPPLIES CO., LTD 57ccc28b-5f5f-30ec-e063-6294a90a081c 2026-09-07 Warnings Exact identifier application number: M003 hand sanitizer - cherry sundae ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 270d2ce0-6310-4a84-be8a-72db6062bae7 2026-09-07 Warnings Exact identifier application number: M003 hand sanitizer - vanilla frosting ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. f6cabda2-6e1c-4238-9a2e-df10e263517d 2026-09-07 Warnings Exact identifier application number: M003 hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. ba3612b3-9696-417a-ba66-eb9dc5ea27c6 2026-09-07 Warnings Exact identifier application number: M003 hydrating mist hand sanitizer with silicone keychain holder - signature scent ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 5b0ac694-66e0-437f-86cd-09f259344b89 2026-09-07 Warnings Exact identifier application number: M003 Sweethearts - Crush On You - Peach Skin ALCOHOL Scent Theory Products LLC 5ac32582-d888-edf4-e063-6394a90a40ab 2026-09-05 Warnings Exact identifier application number: M003 Sweethearts - Be Mine - Sugared Berries ALCOHOL Scent Theory Products LLC 5ac32ffb-926a-f249-e063-6394a90a8d87 2026-09-05 Warnings Exact identifier application number: M003 Sweethearts - UR Sweet - Sweet Cherry Hand Sanitizer ALCOHOL Scent Theory Products LLC 5ac33b21-9192-8baa-e063-6294a90a6e75 2026-09-05 Warnings Exact identifier application number: M003 Sweethearts - Ooo La La - Banana Cream Hand Sanitizer ALCOHOL Scent Theory Products LLC 5ac34dda-fbdf-0ca7-e063-6394a90ab764 2026-09-05 Warnings Exact identifier application number: M003 SurviveX PREP WIPES ALCOHOL PREP PAD Changzhou Maokang Medical Products Co., Ltd. 5a7e9dc6-cf43-7ffc-e063-6394a90a3faa 2026-09-04 Warnings Exact identifier application number: M003 Members Mark ISOPROPYL ALCOHOL Sams West Inc c251ac50-f74f-4a48-e053-2a95a90aac0d 2026-09-04 Warnings Exact identifier application number: M003 Walmart ISOPROPYL ALCOHOL Walmart, Inc. 2f1342ef-1843-40a6-e063-6294a90a577f 2026-09-04 Warnings Exact identifier application number: M003 Curad Alcohol Prep Pads Medium ISOPROPYL ALCOHOL Medline Industries, LP 1ce3872e-2307-4a38-bd7d-7eb2b226cf3c 2026-09-04 Warnings Exact identifier application number: M003 Alcohol ISOPROPYL ALCOHOL SuperValu, Inc. 5e6e6d6f-4472-40f1-b0a9-96cee7ef075b 2026-09-04 Warnings Exact identifier application number: M003 Alcohol ISOPROPYL ALCOHOL Foodhold U.S.A. LLC a94c023c-5313-4940-90a7-b3061a8b90e1 2026-09-04 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