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 71 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Luxury Hand Sanitizer Whispering Woods ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 394e4b3a-5832-9f8d-e063-6294a90ac449 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Botanic Blush ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62434b-c2a9-bd39-e063-6294a90af8b3 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Golden Grove ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62805a-7834-8a27-e063-6394a90a67fe 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Citrus Suede ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62ecc5-4252-a002-e063-6394a90ace3e 2025-08-15 Warnings Exact identifier application number: M003 AmeriDerm Antibacterial Wash PARACHLOROMETAXYLENOL SHIELD LINE LLC 6e652a7d-76bb-bb2d-e053-2a91aa0aac50 2025-08-15 Warnings Exact identifier application number: M003 AMERIWASH PARACHLOROMETAXYLENOL SHIELD LINE LLC 6d5ed0f9-fb48-7855-e053-2991aa0a18a8 2025-08-15 Warnings Exact identifier application number: M003 365 Whole Foods Market Refreshing Hand Sanitizer Bergamot Rain ETHYL ALCOHOL Whole Foods Market, Inc. 3c6b1a51-4097-1aad-e063-6294a90aef6f 2025-08-15 Warnings Exact identifier application number: M003 MedPride Bath Wipes BENZALKONIUM CHLORIDE Shield Line LLC ecf7e545-21ca-bbe0-e053-2995a90a9a55 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Midnight Musk ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c5f46b4-f202-2a44-e063-6294a90ac106 2025-08-14 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Meadow Mirage ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c5f8420-9673-6f77-e063-6294a90a81e4 2025-08-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Coconut Breeze ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3af609-d342-449a-e063-6294a90a0a19 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Fresh Rain ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3bd802-56de-ebcd-e063-6294a90aca15 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Wild Rose ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3c78f6-e6cb-e456-e063-6394a90ac5b8 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Champagne Toast ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c4bceac-21bc-486e-e063-6394a90a0f37 2025-08-13 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 3c25e093-0335-fa1d-e063-6394a90ae684 2025-08-12 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 3c266de8-0551-374c-e063-6394a90ab9f4 2025-08-12 Warnings Exact identifier application number: M003 Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE HAIAN KANGRUI TEXTILE CO., LTD. 3c273544-4562-8f37-e063-6394a90ab4d3 2025-08-12 Warnings Exact identifier application number: M003 HealthWise Lidocaine Cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE Veridian Healthcare 6022803a-097e-41c6-b9ee-48c8ef380d7a 2025-08-12 Warnings Exact identifier application number: M003 Hand Sanitizer Wipes ISOPROPYL ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c37f72b-623c-c8f6-e063-6294a90a971e 2025-08-12 Warnings Exact identifier application number: M003 HAND SANITIZER VANILLA ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3c236c0b-fccd-6992-e063-6294a90a37ce 2025-08-11 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