Home NDC 49348-133-27 Sunmark Iodine
Product NDC 49348-133
Requested package NDC 49348-133-27
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 · 1 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 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 40 of 114 · 2,270 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Exact identifier application number: M003 SPA HAND SANITIZER SUMMER LEMON ETHYL ALCOHOL Rejoice International Corp. 48dd563a-0558-cc76-e063-6294a90ab041 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48de4a31-c620-6c1c-e063-6394a90abb96 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48df981a-74da-a629-e063-6294a90a7f40 2026-01-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487b648a-1680-6de5-e063-6394a90ab852 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487e6851-1ca3-f9db-e063-6394a90a56f1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Exact identifier application number: M003 NEXXGEN 50% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC d48232ab-ab55-488a-9cc1-77c8d0ba992e 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 486ee2e0-2222-0574-e063-6294a90a9eff 2026-01-15 Warnings Exact identifier application number: M003 Benzalkonium Chloride SANITIZING HAND WIPES ALO NEW YORK LLC d3afde78-b9f6-3648-e053-2a95a90a4024 2026-01-15 Warnings Exact identifier application number: M003 BIOPURE Hand Sanitizer Spray-Coastal Glow HAND SANITIZER SPRAY Quest USA Corp 48254577-9f1e-9389-e063-6394a90a92f1 2026-01-15 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487a4c8e-4fb3-6bff-e063-6294a90abd53 2026-01-15 Warnings Exact identifier application number: M003 Gold Bond Hydrating Hand Sanitizer ETHYL ALCOHOL Chattem, Inc. 96fe0191-0d34-4bf3-8f93-0e64764c353a 2026-01-14 Warnings Exact identifier application number: M003 Alcohol Prep Awabs ISOPROPYL ALCOHOL Enlightening Pallet Industry Co., Limited 26c7db1e-86a9-8765-e063-6294a90a634f 2026-01-14 Warnings Exact identifier application number: M003 Caring Hands HAND MOISTURIZING SANITIZER Gleeco Labs LLC 2ced5dc5-47dd-1b71-e063-6394a90a0e3d 2026-01-14 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL DealMed Medical Supplies LLC 04e6edb5-07ef-4ed4-ba68-ed183386b5ab 2026-01-13 Warnings Exact identifier application number: M003 Dermoplast First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC ec93011d-7069-4021-8dd2-3d51eb6026e1 2026-01-13 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