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 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 109 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ethyl Rubbing Alcohol 70 Percent ETHYL ALCOHOL Pharma Nobis, LLC e42fccc2-1b50-e7f3-e053-2a95a90aef39 2023-12-26 Warnings Exact identifier application number: M003 Isopropyl Alcohol 70 Percent With Wintergreen Oil ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e1-02c6-e053-2995a90a3ace 2023-12-26 Warnings Exact identifier application number: M003 CVS Merthiolate BENZALKONIUM CHLORIDE CVS Pharmacy dd498ab1-8350-41aa-86fc-2db57005f3e2 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Pharma Nobis, LLC e42eee1b-3539-fb17-e053-2995a90af61d 2023-12-22 Warnings Exact identifier application number: M003 Decolorized Iodine ETHYL ALCOHOL Pharma Nobis, LLC e21dd43b-3712-cb16-e053-2a95a90ac276 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f727c-beb0-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE GARGLE 0.5% Pharma Nobis, LLC e42ee827-b350-7b56-e053-2a95a90a69cf 2023-12-22 Warnings Exact identifier application number: M003 Merthiolate BENZALKONIUM CHLORIDE Pharma Nobis, LLC e42f727c-beaf-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Alcohol 91 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e0-02c6-e053-2995a90a3ace 2023-12-22 Warnings Exact identifier application number: M003 RevitaDERM Wound Care BENZALKONIUM CHLORIDE Blaine Labs Inc. 9254dada-4e32-43a0-892b-c488d68e23e7 2023-12-21 Warnings Exact identifier application number: M003 NUMSTAT Antiseptic and Pain Relieving Prep Pad ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD Spectra Medical Devices, LLC 07d20040-9dd9-0aba-e063-6294a90ab7cf 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Iodides ALCOHOL Strategic Sourcing Services LLC 8d9f2112-c678-4559-b567-9d6d287c5fa3 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Strategic Sourcing Services LLC 72eeb3e6-c0a1-4b18-87f1-8db06f9bd111 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Strategic Sourcing Services LLC cbe02fa1-c167-4b77-8f63-817362090e19 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Isopropyl Alcohol 91 Percent ISOPROPYL ALCOHOL Strategic Sourcing Services LLC fbd2aa69-b1c7-4a28-9642-a436ae09faaf 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Povidone Iodine POVIDONE IODINE 10% Chain Drug Market Association 9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Chain Drug Market Association 55c970ed-13a9-4ea2-a8cb-aaf14d3a214d 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Iodides Tincture ETHYL ALCOHOL Chain Drug Market Association 71aedfd5-e81f-4b69-b163-527ff1ce30b1 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Merthiolate BENZALKONIUM CHLORIDE Chain Drug Market Association 5b7303b9-b8c4-4e7c-876f-70ed76443055 2023-12-20 Warnings Exact identifier application number: M003 Premier Value Povidone Iodine POVIDONE IODINE 10% Chain Drug Consortium 5cc9d782-5f7e-27d9-e053-2991aa0a2428 2023-12-20 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