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 48 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freshnap Plus - 80% Ethyl Alcohol Towelette ALCOHOL TOWELETTE KARI-OUT LLC f4ae66e3-323b-5e2e-e053-2995a90acf42 2025-12-27 Warnings Exact identifier application number: M003 Guardelle BENZALKONIUM CHLORIDE Social Medical Supply LLC 8793e3be-7409-4f71-9397-abbeacd27cf8 2025-12-22 Warnings Exact identifier application number: M003 CareALL First Aid Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCL New World Imports, Inc 69eef888-0044-485c-96a1-247ed1204858 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Pear Blossom Tea ALCOHOL SOLUTION Noshinku 46927edb-f8be-f0b9-e063-6294a90a8e56 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Santal Blanc ALCOHOL SOLUTION Noshinku 4692c807-268e-6477-e063-6394a90aac0a 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Vanilla Creme ALCOHOL SOLUTION Noshinku 4692e68c-2bc8-83f8-e063-6294a90a84e4 2025-12-22 Warnings Exact identifier application number: M003 Alcohol sanitizer wipes ALCOHOL/PURIFIED WATER SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. ab9634bd-4226-2f73-e053-2995a90a802f 2025-12-19 Warnings Exact identifier application number: M003 Sanitizing Wipes BENZALKONIUM CHLORIDE Wipes LLC 9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3 2025-12-19 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 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