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 106 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe ETHYL ALCOHOL Rejoice International 2851ad2a-e108-424c-86d6-c898567695ef 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Hand Sanitizer Moisturize with Vitamin E ETHYL ALCOHOL Rejoice International 13c99570-0859-4310-843a-5eb266698eb3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International a339dfd9-7cb8-4198-bc2a-9759648cf34e 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72 2024-02-28 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd 11ef87cc-6ff6-511b-e063-6294a90a662f 2024-02-21 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL MY IMPORTS USA LLC 11f19126-6abb-b14c-e063-6294a90a4e34 2024-02-21 Warnings Exact identifier application number: M003 Antiseptic ANTISEPTIC SPRAY Dynarex Corporation 118192ac-7173-09c5-e063-6394a90ad550 2024-02-16 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL SPRAY Dynarex Corporation 116e0c9c-cbe0-bf67-e063-6394a90ae530 2024-02-15 Warnings Exact identifier application number: M003 POVIDONE-IODINE POVIDONE-IODINE HART Health 92b6a38e-c7bb-45e2-9c2a-7993ed1bac36 2024-02-15 Warnings Exact identifier application number: M003 Povidone Iodine Gel Swabstick POVIDONE IODINE GEL SWABSTICK Dynarex Corporation eb7e21be-521e-2d52-e053-2a95a90ade33 2024-02-13 Warnings Exact identifier application number: M003 Antiseptic ALCOHOL, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 71aeaf86-2b4d-4945-9606-a9db0ab6b726 2024-02-07 Warnings Exact identifier application number: M003 Antiseptic BENZALKONIUM CHLORIDE, BENZOCAINE Safetec of America, Inc. 458e65f2-826d-4550-8c7d-17add2d7ba9a 2024-02-07 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Safetec of America, Inc. a665e2ce-c7e1-4d79-aa58-da7595944e7f 2024-02-07 Warnings Exact identifier application number: M003 First Aid and Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 47cb6921-5d82-4123-a9e0-0b05d4dcb5b2 2024-02-07 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 0fbf0078-3660-fe5c-e063-6394a90afc2d 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with aloe vera ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc032af-26bc-0e8b-e063-6294a90a91b0 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 16.9oz with vitamin E ETHYL ALCOHOL Midwood Brands, LLC 0fc0bd79-ddd7-b9d1-e063-6394a90adc69 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc0970d-06a6-ade9-e063-6394a90ae7ff 2024-01-25 Warnings Exact identifier application number: M003 Target Up and Up Pain Relieving Cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE TARGET CORPORATION 0f964747-be02-c715-e063-6294a90ad91e 2024-01-25 Warnings Exact identifier application number: M003 SannyTize Hand Sanitizer HAND SANITIZER Dynarex Corporation 968713a5-64d3-86fc-e053-2995a90a088a 2024-01-24 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