Home NDC 49348-133 Sunmark Iodine
Product NDC 49348-133
11-digit product format 493480133
Labeler code 49348
Product ID 49348-133_0ce55ce7-d710-5b31-e063-6294a90a7ab7
Type HUMAN OTC DRUG
Nonproprietary name IODINE, SODIUM IODIDE, ALCOHOL
Dosage form TINCTURE
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-28
Substance IODINE; ALCOHOL; SODIUM IODIDE
Active strength 20; 470; 24 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 49348-133 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49348-133 49348-133-27 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 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 Sunmark Iodine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IODINE 20 mg/mL ALCOHOL 470 mg/mL SODIUM IODIDE 24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9679TC07X4 Internal UNII lookup 3K9958V90M Internal UNII lookup F5WR8N145C Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49348-133-27 Sunmark Iodine 30 mL in 1 BOTTLE TINCTURE 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCOHOL ACTIVE INGREDIENT 3K9958V90M SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 IODINE ACTIVE INGREDIENT 9679TC07X4 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 SODIUM IODIDE ACTIVE INGREDIENT F5WR8N145C SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 ALCOHOL ACTIVE MOIETY 3K9958V90M SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 IODINE ACTIVE MOIETY 9679TC07X4 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [MCKESSON] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-133 SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [STRATEGIC SOURCING SERVICES LLC] 7 Current NDC, Legacy NDC, 1 package rows 20231220_e8dae2d6-58b1-4c4e-a4c1-371db055b7ae.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 114 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antiseptic BZK Towelette BENZALKONIUM CHLORIDE Cardinal Health 200, Inc. 8dd79ffe-f742-438c-9814-612f900ad6a9 2023-10-23 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd f231a572-a99d-4146-afa3-e73ea1cee027 2023-10-22 Warnings Exact identifier application number: M003 Povidone Iodine Topical Solution Paint POVIDONE IODINE 10% Jianerkang Medical Co., Ltd 42778607-6170-4a5e-94d0-5e6cd064eec6 2023-10-22 Warnings Exact identifier application number: M003 Alcohol ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 76048b01-28f3-4e43-9da9-974b2b511a10 2023-10-22 Warnings Exact identifier application number: M003 GENUINE FIRST AID Antiseptic Hand Sanitizer ETHYL ALCOHOL Nantong Health & Beyond Hygienic Products Inc. d25f02f1-268c-44d8-9a55-c6efcbe8eed1 2023-10-19 Warnings Exact identifier application number: M003 Brompton and Langley Moisturizing Hand Sanitizer Lavnder Vanilla ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 90bd3436-a8bc-4c19-a300-d59236a8de27 2023-10-19 Warnings Exact identifier application number: M003 Up and Up 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Target Corporation becc8fe3-eaf5-4429-b462-a87dd09c4db8 2023-10-17 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 766ad4df-2100-4f26-bd8b-5c5a0918698e 2023-10-13 Warnings Exact identifier application number: M003 GoodSense Alcohol Swabs ISOPROPYL ALCOHOL Geiss, Destin and Dunn 968bab9f-5b74-270b-e053-2995a90a0df4 2023-10-13 Warnings Exact identifier application number: M003 Henry Schein Povidone-Iodine Swabsticks POVIDONE-IODINE Henry Schein, Inc. 5854f241-6cfc-4e5a-ba72-92dd0703f728 2023-10-13 Warnings Exact identifier application number: M003 DawnMist Alcohol Hand Sanitizer ALCOHOL Dukal LLC a2df96a9-8514-6839-e053-2a95a90a9417 2023-10-13 Warnings Exact identifier application number: M003 DUKAL STING RELIEF PAD BENZOCAINE Dukal LLC 67c1ddc7-8fde-4431-84cb-f757682d5f3e 2023-10-13 Warnings Exact identifier application number: M003 First Aid Only First Aid/Burn LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE Acme United Corporation 07245b54-b193-178e-e063-6394a90a2581 2023-10-09 Warnings Exact identifier application number: M003 Hand sanitizer 2oz 2pk original ETHYL ALCOHOL Rejoice International Corp. 06dc1730-216a-8b4d-e063-6294a90a4184 2023-10-04 Warnings Exact identifier application number: M003 Hand sanitizer 1.8oz with extra clip original ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 06dcf8dc-0831-475e-e063-6394a90a9fef 2023-10-04 Warnings Exact identifier application number: M003 Hand sanitizer 2oz 2pk original ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 06dd2427-097c-b0fa-e063-6294a90a4f82 2023-10-04 Warnings Exact identifier application number: M003 Hand sanitizer 1.8oz with extra clip original ETHYL ALCOHOL Rejoice International Corp. 06da0cc1-95f2-4f88-e063-6394a90a25ea 2023-10-03 Warnings Exact identifier application number: M003 First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite Aid ISOPROPYL ALCOHOL Rite Aid Corporation aa0df5fe-62d1-407d-b8f9-a7fd9473d569 2023-10-02 Warnings Exact identifier application number: M003 Foaming Instant Hand Sanitizer with Aloe ETHANOL MCKESSON MEDICAL-SURGICAL INC. 5c1f69b7-c8d8-477c-b614-47a3287b0e4c 2023-06-05 Warnings Exact identifier application number: M003 Bactine Max Dry LIDOCAINE HYDROCHLORIDE WellSpring Pharmaceutical Corporation 466404cd-c46a-4944-b1ac-3b3b17f436a1 2022-12-27 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-133-27 49348013327 30 mL in 1 BOTTLE (49348-133-27) 30 ml 2019-08-23 0000-00-00 No No Current