Home NDC 67618-153 Betadine
Product NDC 67618-153
11-digit product format 676180153
Labeler code 67618
Product ID 67618-153_4357dde4-a121-3be4-e063-6394a90af3c8
Type HUMAN OTC DRUG
Nonproprietary name POVIDONE-IODINE
Dosage form SOLUTION
Route TOPICAL
Labeler Atlantis Consumer Healthcare, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 1972-09-15
Substance POVIDONE-IODINE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67618-153-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67618-153-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67618-153-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67618-153-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67618-153-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67618-153-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67618-153-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67618-153-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67618-153-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67618-153-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67618-153-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67618-153-03 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67618-153-01 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67618-153-03 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 67618-153-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 67618-153-03 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 67618-153-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 67618-153-03 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 67618-153-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 67618-153-03 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67618-153-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67618-153-03 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Betadine
Brand name suffix Solution Swabsticks
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 85H0HZU99M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797730 Internal RxNorm lookup 798176 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 67618-153-01 2022-04-09 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-01 2022-04-09 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-03 2022-04-09 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-03 2022-04-09 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-01 2020-01-31 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-01 2020-01-31 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-03 2020-01-31 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts 67618-153-03 2020-01-31 BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67618-153-01 BetadineSolution Swabsticks 1.9 mL in 1 APPLICATOR SOLUTION 1.9 8 67618-153-01 BetadineSolution Swabsticks 1 in 1 POUCH SOLUTION 1 8 67618-153-03 BetadineSolution Swabsticks 1.9 mL in 1 APPLICATOR SOLUTION 1.9 8 67618-153-03 BetadineSolution Swabsticks 3 in 1 POUCH SOLUTION 3 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67618-153 BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20250101_0707b259-52a4-4ae6-b176-d093865906e7.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 93 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Univ of Vermont Medical Center Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7841cfa9-e94e-4c3d-b5fb-676924017845 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Mothers Vaginal ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7f1a85fd-086b-4fc7-abac-863dd3ea505a 2024-12-17 Warnings Exact identifier application number: M003 Mary Kay Satin Hands Shea Hand Sanitizer ALCOHOL Mary Kay Inc. b6c2b979-2940-1569-e053-2995a90a532c 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive Decolorized Iodine ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981529a-2bd0-3e9e-e063-6294a90a7236 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981cb97-17de-ebda-e063-6394a90ad281 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital H.E.A.R.T. Strings Tote ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc f8369a27-1995-4fdd-a282-35c344c11d83 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 877ce875-c5b0-4d9b-8f00-682914e3bc0e 2024-12-17 Warnings Exact identifier application number: M003 Wellstar Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc ced9dd96-7922-43d7-906f-32afaad733ec 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital C-Section Mothers ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 9df6d0e9-631c-4619-9d96-d2c5a32a590e 2024-12-17 Warnings Exact identifier application number: M003 Memorial Sloan Kettering Cancer Center Amenity Kit SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc cab0bef1-f486-4eac-a61b-6030467d8650 2024-12-17 Warnings Exact identifier application number: M003 Sarasota Memorial Amenity ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc f5dda019-fcfd-4e99-89cc-e79e76b402e7 2024-12-17 Warnings Exact identifier application number: M003 Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67618-153-01 67618015301 1 APPLICATOR in 1 POUCH (67618-153-01) > 1.9 mL in 1 APPLICATOR 1 applicator 1972-09-15 0000-00-00 No No Current 67618-153-03 67618015303 3 APPLICATOR in 1 POUCH (67618-153-03) > 1.9 mL in 1 APPLICATOR 3 applicator 1972-09-15 0000-00-00 No No Current