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 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 · 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 2026-12-31 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 11 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Humco Gentian Violet 2% GENTIAN VIOLET 2% Humco Holding Group, Inc. a07f61e5-0215-419a-a68a-1d814417c35f 2026-07-09 Warnings Exact identifier application number: M003 GNP Gentian Violet 1% GENTIAN VIOLET 1% Amerrisource Bergen 5d07274f-e848-6c60-e053-2991aa0a40d8 2026-07-09 Warnings Exact identifier application number: M003 Drs pharmacy triple antibiotic Pain plus itch plus Scar BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT OL PHARMA TECH, LLC 16273878-2f58-0d26-e063-6394a90a47d2 2026-07-09 Warnings Exact identifier application number: M003 Drs. Pharmacy Triple Antibiotic Plus Pain relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE OL PHARMA TECH, LLC Drs PHARMACY 1626fa89-cec0-6467-e063-6294a90aa2a4 2026-07-09 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 56148c12-7d6f-26bf-e063-6294a90a93df 2026-07-08 Warnings Exact identifier application number: M003 Povidone-Iodine POVIDONE-IODINE CARDINAL HEALTH 110, LLC. DBA LEADER 4f0d8da5-a75b-acc7-e063-6394a90ae839 2026-07-08 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 5600cf8a-5aba-1a22-e063-6394a90a8083 2026-07-07 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5600dc30-192d-19b1-e063-6394a90a66d3 2026-07-07 Warnings Exact identifier application number: M003 70% ISOPROPYL ALCOHOL Save-A-Lot Food Stores Ltd a592326c-c062-4ebf-b8dd-83f7e6f2f22b 2026-07-07 Warnings, Adverse reactions Exact identifier application number: M003 Amazon Basics Citrus Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 52e5b1a4-3a84-c4cb-e063-6394a90a822c 2026-07-07 Warnings Exact identifier application number: M003 Amazon Basics Fresh Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 5256f38a-74b6-0d18-e063-6294a90a5b46 2026-07-07 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL EverywhereAire LLC b48f9e6b-c616-3607-e053-2995a90a37f5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer ETHYL ALCOHOL EverywhereAire LLC b6af3009-78c2-2312-e053-2995a90af90a 2026-07-06 Warnings Exact identifier application number: M003 Hand Sanitizer gel ALCOHOL EverywhereAire LLC d2a6c866-3f1e-20f1-e053-2995a90a26cc 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab3ab67-cb27-6c2b-e053-2a95a90ace12 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Sandalwood ETHANOL HAND SANITIZER EverywhereAire LLC 18612a10-8667-b0ef-e063-6394a90a208e 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands ETHANOL HAND SANITIZER EverywhereAire LLC b86824c2-4fae-d597-e053-2995a90ad1da 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Lemon Olive Oil Hand Sanitizer ETHANOL HAND SANITIZER EverywhereAire LLC 42f8c2fb-a4e6-9416-e063-6294a90af9d5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL BASED EverywhereAire LLc eab52ae1-f588-b08b-e053-2995a90a96b2 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab19649-21fc-2fa4-e053-2995a90a90f9 2026-07-06 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