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 86 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Cucumber Melon ETHYL ALCOHOL Rejoice International 021fa2a0-d2ea-4699-a3d8-3c0af18c5aa3 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Lavender Chamomile ETHYL ALCOHOL Rejoice International 6e611e87-1835-49f8-aa52-b724bd251527 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Sweet Pea Blossom ETHYL ALCOHOL Rejoice International 1a5408f2-910c-4c6a-b6b3-c1304dd1cdf0 2025-02-12 Warnings Exact identifier application number: M003 XtraCare Warm Vanilla ETHYL ALCOHOL Rejoice International 46e7b4fa-3722-4487-9325-f8552ea92acf 2025-02-12 Warnings Exact identifier application number: M003 Instant Hand Sanitizer 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 5b209df6-d896-170c-e053-2a91aa0a52a8 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e62eb50-ebb8-361e-e053-2991aa0aba6f 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e6585a3-61e1-30ec-e053-2a91aa0a6039 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Spider Man 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dedab76-3f5a-febf-e063-6394a90a6993 2025-02-12 Warnings Exact identifier application number: M003 Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus pack ETHYL ALCOHOL Rejoice International Inc. 6e65856c-0e14-1ab6-e053-2991aa0a3f3e 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Barbie 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfd2ffd-a85a-f63e-e063-6294a90a6a5e 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Crayola 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfd4acb-451b-12d3-e063-6294a90a4873 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Assorted Licensed Sanitizer Hot Wheels 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfdd225-24f4-6d57-e063-6394a90a8a24 2025-02-12 Warnings Exact identifier application number: M003 Smart Care Cucumber Melon Hand Sanitizer 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2dfe0ac7-99d5-aac3-e063-6294a90a31b3 2025-02-12 Warnings Exact identifier application number: M003 Isopropyl alcohol 70 percent ISOPROPYL ALCOHOL Good Sense (Geiss, Destin & Dunn, Inc.) ac66be77-d358-44ea-8904-88186a7c2bbb 2025-02-07 Warnings Exact identifier application number: M003 Rubbing Alcohol 70 Percent Isopropyl ISOPROPYL ALCOHOL Harris Teeter, LLC 4196dd97-9041-4712-8196-02237a3b0cb2 2025-02-07 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Harris Teeter, LLC 1b044f47-45e1-40a3-81b0-2717ed425f16 2025-02-07 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e042f5b-3f0c-1830-e054-00144ff88e88 2025-02-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e04fa70-c25d-4499-e054-00144ff8d46c 2025-02-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International Corp. 4e05cceb-b8f3-48f7-e054-00144ff88e88 2025-02-06 Warnings Exact identifier application number: M003 Hand Sanitizer 1.8 oz Antiseptic ETHYL ALCOHOL REJOICE INTERNATIONAL CORP. a0313f20-11dc-6c7d-e053-2a95a90a60f1 2025-02-06 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