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 45 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biopure Antibacterial Hand Wipe Berry Strawberry BENZALKONIUM CHLORIDE Quest USA Corp 47d6574c-0d4c-392e-e063-6394a90a590f 2026-01-07 Warnings Exact identifier application number: M003 Biopure Antibacterial Hand Wipe Vallina Dream BENZALKONIUM CHLORIDE Quest USA Corp 47d7090d-036b-870b-e063-6394a90a80c3 2026-01-07 Warnings Exact identifier application number: M003 99 Plus Hand Sanitizer BENZEALKONIUM CHLORIDE Momar Incorporated f972a8f1-c928-4e4b-a8dd-a2fb77052d21 2026-01-06 Warnings Exact identifier application number: M003 Benzocaine BENZOCAINE Dynarex Corporation 6161e94c-7849-466e-8da3-a6f1b085bdf9 2026-01-06 Warnings Exact identifier application number: M003 Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent BENZALKONIUM CHLORIDE Quest USA Corp 47c105a8-7c76-9cde-e063-6294a90a9284 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER VANILLA ETHYL ALCOHOL Rejoice International Corp. 47c3c187-da54-7c3b-e063-6294a90af3ce 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER CHAMPAGNE BLASH ETHYL ALCOHOL Rejoice International Corp. 47c5e9af-4ea8-fb39-e063-6394a90aa5ab 2026-01-06 Warnings Exact identifier application number: M003 Antiseptic Cleaning wipe ANTISEPTIC CLEANING WIPE SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d01ae-d99e-bce3-e063-6294a90a1a2d 2026-01-05 Warnings Exact identifier application number: M003 Povidone-lodine prep pad POVIDONE-LODINE PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 201545b8-0697-5601-e063-6394a90a12f4 2026-01-05 Warnings Exact identifier application number: M003 Sting Relief prep Pad STING RELIEF PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 202c7b77-1a48-52a5-e063-6394a90a2eb2 2026-01-05 Warnings Exact identifier application number: M003 Skin Cleaning Care Wipes SKIN CLEANING CARE WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d7a95-65fe-ca65-e063-6294a90acc6e 2026-01-05 Warnings Exact identifier application number: M003 ANTISEPTIC CLEANSING WIPE(0.9% NACL) ANTISEPTIC CLEANSING WIPE(0.9% NACL) SHENZHEN BENLIJU BIO-TECH CO.,LTD 33e1c026-8a35-a47a-e063-6294a90a2406 2026-01-05 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes HAND SANITIZING WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 37487da6-4e0e-6625-e063-6394a90a0af1 2026-01-05 Warnings Exact identifier application number: M003 Hand wipes HAND WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 39f3acca-7275-88ca-e063-6394a90ad1a2 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Vanilla Heaven ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a0781b-9b25-f04b-e063-6294a90ae7e5 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a16397-dff3-7d79-e063-6394a90a040f 2026-01-05 Warnings Exact identifier application number: M003 IDOSWAB B ISOPROPYL ALCOHOL IDO PHARM 16d19630-b67a-f3e1-e063-6394a90a7429 2026-01-05 Warnings Exact identifier application number: M003 Sure Comfort Alcohol Prep Pads ISOPROPYL ALCOHOL IDO PHARM 27def94b-d3a6-18b7-e063-6394a90a22a6 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Lemon Lime ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeaae9-740d-a28a-e063-6294a90a6460 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Calming Lavender ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeeef9-0eed-e7d0-e063-6394a90a6d31 2026-01-05 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