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 104 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Swabs ISOPROPYL ALCOHOL McKesson 4650c945-8e38-5ad9-e054-00144ff8d46c 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER COCONUT BREEZE ALCOHOL SCENT THEORY PRODUCTS LLC 1a5152b3-d674-f69a-e063-6394a90a6cac 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER REBEL CHERRY ALCOHOL SCENT THEORY PRODUCTS LLC 1a503858-4d2f-8e32-e063-6294a90ade97 2024-06-07 Warnings Exact identifier application number: M003 Antiseptic Wipe BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 1a3c5fc9-70cc-e857-e063-6294a90a3424 2024-06-06 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Wildman Business Group 1f95b277-e40c-4a17-e063-6294a90a1127 2024-06-01 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. dbfdecf0-a961-4cc5-bf87-ae30bbc302dd 2024-05-31 Warnings Exact identifier application number: M003 hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a6c3c6-4b27-9011-e063-6394a90ae512 2024-05-30 Warnings Exact identifier application number: M003 antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a7b2fc-239c-b53c-e063-6394a90a0906 2024-05-30 Warnings Exact identifier application number: M003 MyMedic Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 197fc623-2fb9-184c-e063-6394a90a4104 2024-05-28 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Limon ALCOHOL Noshinku d70fba7a-513f-0341-e053-2a95a90add86 2024-05-15 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Vetiver ALCOHOL Noshinku d70fb84c-fdbc-6ba8-e053-2995a90ab529 2024-05-15 Warnings Exact identifier application number: M003 Safly BZK Antiseptic Towelette BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 5cd9043e-daf2-43eb-9568-54775fc4f84a 2024-05-15 Warnings Exact identifier application number: M003 Noshinku Bergamot Hand Sanitizer ALCOHOL Noshinku 53fea81e-4482-6fae-e054-00144ff8d46c 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Eucalyptus Hand Sanitizer ALCOHOL Noshinku 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Lavender Hand Sanitizer ALCOHOL Noshinku a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf 2024-05-14 Warnings Exact identifier application number: M003 LEADER 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Cardinal Health, 110 dba Leader 7f810b92-60f6-2f72-e053-2991aa0ab973 2024-05-13 Warnings Exact identifier application number: M003 Leader Decolorized Iodine ALCOHOL LIQUID Cardinal Health, 110 dba Leader 822f6f28-956f-dd82-e053-2991aa0ae752 2024-05-13 Warnings Exact identifier application number: M003 Inverness Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a2995-334c-2e93-e063-6294a90aecf7 2024-05-09 Warnings Exact identifier application number: M003 Helzberg Diamonds Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a3776-0edd-26f3-e063-6294a90a740d 2024-05-09 Warnings Exact identifier application number: M003 Ulta Beauty Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a37f4-8718-3e40-e063-6294a90acaad 2024-05-09 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