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 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 52 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Humco Holding Group, Inc. 41c0927e-df40-4f83-8fd4-284ec0c02b60 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Strawberry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 451752d3-88bc-9a26-e063-6294a90a288a 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 45179a84-fa3c-5634-e063-6294a90a0eee 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 451711f3-3b22-5d39-e063-6294a90a7894 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4518038c-04ac-0fbe-e063-6294a90a7c32 2025-12-03 Warnings Exact identifier application number: M003 Hand sanitizer HAND SANITIZER SPRAY Guangzhou Baihua Co., Ltd 44f609dd-c864-493f-e063-6294a90a7138 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer Watermelon ALCOHOL Longway Technology(Guangzhou) Co., Ltd.- 44fc6694-2933-8700-e063-6294a90a274f 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer coconut ALCOHOL Longway Technology(Guangzhou) Co., Ltd. 44fcf3d3-439b-7869-e063-6294a90a19c3 2025-12-02 Warnings Exact identifier application number: M003 MedPride Instant Sanitizer ALCOHOL SHIELD LINE LLC a1c87c06-d4d2-cd0f-e053-2995a90a4eaa 2025-12-02 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Caramel Honey ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 450401c9-2098-9a23-e063-6394a90a2084 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer Cherry ALCOHOL Longway Technology(Guangzhou) Co., Ltd. 44e04959-a21e-ba62-e063-6394a90a7192 2025-12-01 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL L&R Distributors, Inc. 263457cc-35ff-62fb-e063-6394a90a94da 2025-12-01 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL L&R Distributors, Inc. 2507df2c-9069-01c1-e063-6394a90a8596 2025-12-01 Warnings Exact identifier application number: M003 T.N. Dickinsons Wound Cleansing BENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE Dickinson Brands Inc. c2a8b134-8bb3-4e00-9df4-3229cb372da0 2025-12-01 Warnings Exact identifier application number: M003 safeHands Hand Sanitizer Clean Linen BENZALKONIUM CHLORIDE Safehands Distribution Ne, LLC 86cc04dc-b66d-4d97-b8da-f5e41f2d13d5 2025-11-29 Warnings Exact identifier application number: M003 safeHands Hand Sanitizer Fragrance Free BENZALKONIUM CHLORIDE Safehands Distribution Ne, LLC 0e7af9f7-80a1-4347-89c4-7d9c8b55d65d 2025-11-29 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 5376a031-b657-47d4-bf41-c393fdec040b 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 2298e131-3b0c-4104-bf48-5c366d763d45 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC be8b96a2-c4a2-41f8-959b-0fe349cff37e 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC b35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee 2025-11-28 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