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 53 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC cef2d3d4-bd5f-4f2a-bb2d-5292b78501c1 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 90d6fe21-7b41-4429-8c03-4d35e66a3b29 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 87aaabb6-d121-464f-993d-5182de13d49e 2025-11-28 Warnings Exact identifier application number: M003 FF SILICONE SPRY SANI PPK FF SILICONE SPRY SANI PPK ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 4493c534-187e-f680-e063-6294a90aacdb 2025-11-27 Warnings Exact identifier application number: M003 Walgreen Maximum strength pain relieving cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE WALGREENS CO. 9a0443a2-f1a9-482d-b5ee-abe983e4ae32 2025-11-26 Warnings Exact identifier application number: M003 Walgreens FIRST AID ANTISEPTIC Walgreens ae731d28-8530-4dd0-aef7-b25f784b4777 2025-11-26 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 44677bab-41ea-3392-e063-6394a90a6187 2025-11-25 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer Spray. ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 3c242e55-4585-9f07-e063-6294a90a6fb4 2025-11-25 Warnings Exact identifier application number: M003 ORANGE HAND SANITIZER aloe and vitamin E ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. a9c1e4f6-e354-4624-a902-8c9154ea4723 2025-11-25 Warnings Exact identifier application number: M003 COCONUT HAND SANITIZER aloe and vitamin E ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 40d7fb84-4b39-440d-a590-8aaf8ec312d7 2025-11-25 Warnings Exact identifier application number: M003 Alcohol Wipes ALCOHOL WIPES Guangzhou Baihua Co., Ltd 4453997f-b885-ad2d-e063-6294a90a2c8e 2025-11-24 Warnings Exact identifier application number: M003 Benzethonium chloride Plus Dyclonine hydrochloride LIQUID BANDAGE VALU MERCHANDISERS, CO c79540fe-b972-41a4-a215-e21e30b903d1 2025-11-24 Warnings Exact identifier application number: M003 Lights Swabsticks ISOPROPYL ALCOHOL Lights Medical Manufacture Co., Ltd. 4435a4e6-46ae-f49b-e063-6394a90a1d9e 2025-11-22 Warnings Exact identifier application number: M003 FloraMedis Hand Sanitizer HAND SANITIZER Sichuan Pengtai Qifan Technology Co., Ltd 4415ca9f-10b1-88f7-e063-6294a90a2e09 2025-11-21 Warnings Exact identifier application number: M003 AMERIDERM BZK SHIELD LINE LLC 440b711a-de12-2d28-e063-6394a90ae42a 2025-11-20 Warnings Exact identifier application number: M003 Recens Foam ALCOHOL Certus Medical, Inc. ea384dfc-c894-3124-e053-2a95a90a81c2 2025-11-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur) ALCOHOL Scent Theory Products LLC 440f0a52-de0a-8f44-e063-6294a90a18b5 2025-11-20 Warnings Exact identifier application number: M003 MK Alcohol Prep Pads Large ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd f1ff70d7-d0f2-45db-96e9-883b54c6e441 2025-11-20 Warnings Exact identifier application number: M003 Aero Care Handy Quat Antiseptic Handwash BENZALKONIUM CHLORIDE ABC Compounding Co., Inc. ab015f59-160a-47d1-8d2f-fbe1b23177b3 2025-11-19 Warnings Exact identifier application number: M003 Fast ALCOHOL ABC Compounding Co., Inc. 4f958247-5370-4250-b2eb-39faa9719939 2025-11-19 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