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 27 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diabetic First Aid Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Lavior Pharma Inc. bda875e6-06bd-930f-e053-2995a90ab197 2026-03-26 Warnings Exact identifier application number: M003 Povidone Iodine Prep Pad ANTISEPTIC Dynarex Corporation 81b475e8-8da4-7b15-e053-2991aa0a6629 2026-03-25 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 4dde3373-1c75-a815-e063-6294a90aa557 2026-03-25 Warnings Exact identifier application number: M003 Los Poblanos Lavender Hand Sanitizer ALCOHOL Sombra Cosmetics Inc. 4ddef71b-f5b8-57f5-e063-6294a90a78a3 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL HAND SANITIZER Dongyang Loulee Cosmetics Co.,Ltd. 48786094-aa70-d0ca-e063-6394a90acd88 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL GEL Dongyang Loulee Cosmetics Co.,Ltd. 487c4724-b618-a071-e063-6394a90aa782 2026-03-25 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe636b-f376-7e30-e063-6394a90a722b 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe7020-e302-8706-e063-6394a90abe7c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe79d2-ee73-a8ed-e063-6394a90a7db5 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe8d3f-afac-cc82-e063-6294a90ae309 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL MY IMPORTS USA LLC 4dcfcd41-b93f-accf-e063-6394a90a963d 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL MY IMPORTS USA LLC 4dd00a64-c0bf-cf7d-e063-6394a90a7692 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL MY IMPORTS USA LLC 4dd010e2-7bcf-666f-e063-6294a90a4f3c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL MY IMPORTS USA LLC 4dd01f13-5ea3-7744-e063-6294a90a124f 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa1aed-d763-2098-e063-6394a90a704b 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa4b88-0ea3-2143-e063-6294a90a69ce 2026-03-23 Warnings Exact identifier application number: M003 povidine iodine POVIDINE IODINE Dynarex Corporation 564ec54b-353e-45a8-85e8-a39f89488d9c 2026-03-23 Warnings Exact identifier application number: M003 DURMA DynaWound Cleanser WOUND CLEANSER Dynarex Corporation 6a4dd82a-6b06-426b-9afd-415a1a4339b4 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc68be-558b-03f0-e063-6394a90aa90d 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc8688-f34b-1178-e063-6394a90a0e67 2026-03-23 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