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 103 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc8a756-852f-6cf8-e063-6394a90a57e6 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Vanilla 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc90b2f-450f-1deb-e063-6394a90a6480 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb4316d-c8c6-3fa2-e063-6394a90a23d2 2024-07-07 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd f531053d-82e4-7613-e053-2995a90a349f 2024-07-02 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd 1ae5c268-1834-4ac2-931e-bb7fd0088cd2 2024-07-02 Warnings Exact identifier application number: M003 Quality Choice ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc 1262c5d7-63ef-f1c1-e063-6294a90a1f0f 2024-07-02 Warnings Exact identifier application number: M003 Genuine First Aid Antiseptic Towelette BENZALKONIUM CHLORIDE GFA Production (Xiamen) Co., Ltd. dfff78d2-e23c-40b2-8a49-8f4140bb0df6 2024-06-25 Warnings Exact identifier application number: M003 Walgreens 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Walgreen Company 03c497cc-c8b1-43b7-86ba-f9f9fc7432bf 2024-06-18 Warnings Exact identifier application number: M003 Antimicrobial BODY CLEANSER McKesson 8ff06cea-3427-5b40-e053-2995a90a0634 2024-06-17 Warnings Exact identifier application number: M003 Swabs ISOPROPYL ALCOHOL McKesson 4650c945-8e38-5ad9-e054-00144ff8d46c 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER COCONUT BREEZE ALCOHOL SCENT THEORY PRODUCTS LLC 1a5152b3-d674-f69a-e063-6394a90a6cac 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER REBEL CHERRY ALCOHOL SCENT THEORY PRODUCTS LLC 1a503858-4d2f-8e32-e063-6294a90ade97 2024-06-07 Warnings Exact identifier application number: M003 Antiseptic Wipe BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 1a3c5fc9-70cc-e857-e063-6294a90a3424 2024-06-06 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Wildman Business Group 1f95b277-e40c-4a17-e063-6294a90a1127 2024-06-01 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. dbfdecf0-a961-4cc5-bf87-ae30bbc302dd 2024-05-31 Warnings Exact identifier application number: M003 hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a6c3c6-4b27-9011-e063-6394a90ae512 2024-05-30 Warnings Exact identifier application number: M003 antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a7b2fc-239c-b53c-e063-6394a90a0906 2024-05-30 Warnings Exact identifier application number: M003 MyMedic Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 197fc623-2fb9-184c-e063-6394a90a4104 2024-05-28 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