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 80 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUPER SUDS ANTIBACTERIAL HAND ITEM 1063 CHLOROXYLENOL AMERICAN CHEMICAL AND SANITARY SUPPLY INC 1871e729-6b76-084e-e063-6394a90a795d 2025-04-23 Warnings Exact identifier application number: M003 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED LIDOCAINE, MENTHOL Compass Health Brands Corp. 2c38a4be-fcbe-9d1d-e063-6294a90a9373 2025-04-22 Warnings Exact identifier application number: M003 Sierra Soft Antibacterial Wash CHLOROXYLENOL CWGC LA Inc. 49034ae5-be47-4472-a4e5-b5bf633355ed 2025-04-21 Warnings Exact identifier application number: M003 Aplicare HYDROGEN PEROXIDE Aplicare Products LLC 0b3e5df6-03c8-3880-e063-6394a90a1cdc 2025-04-18 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Total Resources International b971cc41-fe23-4be3-9564-e46d55df1d68 2025-04-18 Warnings Exact identifier application number: M003 Sierra Soft Alcohol Hand Sanitizer ETHYL ALCOHOL CWGC LA Inc. 012463da-94cf-4975-9fa2-6c323855bf57 2025-04-17 Warnings Exact identifier application number: M003 Biopure HAND SANITIZER SPRAY Quest USA Corp 323c61fd-adee-393c-e063-6394a90a5eb3 2025-04-15 Warnings Exact identifier application number: M003 Biopure HAND SANITIZER SPRAY Quest USA Corp 324b140d-9d43-1c2f-e063-6294a90ae303 2025-04-15 Warnings Exact identifier application number: M003 Isopropyl alcohol 70 percent ISOPROPYL ALCOHOL TARGET Corporation 126ec829-c54c-4927-bbd5-a8156d2f6eea 2025-04-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Apple ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 32b88e9f-d3e7-c78c-e063-6294a90a6707 2025-04-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3269a702-59a3-af3b-e063-6394a90a97d2 2025-04-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Spicy Cranberry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 32b8e946-b52b-fa2e-e063-6294a90ae1a7 2025-04-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 32b920b7-91b4-52df-e063-6394a90a745e 2025-04-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitize Mistletoe ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 32b95351-5115-7200-e063-6394a90a5840 2025-04-14 Warnings Exact identifier application number: M003 Be Smart Get Prepared Alcohol Prep Pad ISOPROPYL ALCOHOL Total Resources International, Inc 6f2a4cb9-eea9-4894-b774-759f27b6f9a8 2025-04-14 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL Strategic Sourcing Services LLC 9c85129b-29fa-4393-a9b4-b8ea1ba5be54 2025-04-14 Warnings Exact identifier application number: M003 Isopropyl alcohol 70 percent Wintergreen ISOPROPYL ALCOHOL TARGET Corporation f4ea4aa4-42c6-456b-9908-24f256d4a769 2025-04-14 Warnings Exact identifier application number: M003 Isopropyl alcohol Wintergreen ISOPROPYL ALCOHOL Strategic Sourcing Services LLC 8dac7168-0140-470f-bf66-fd0aed519b38 2025-04-14 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL Strategic Sourcing Services LLC 227b9292-0be7-47ef-ac8e-a9a8cc2fb416 2025-04-14 Warnings Exact identifier application number: M003 Be Smart Get Prepared Antiseptic Wipe BENZALKONIUM CHLORIDE Total Resources International, Inc f2151af3-d76a-490f-90ff-728c350fe168 2025-04-11 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