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 45 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biopure Antibacterial Hand Wipe Berry Strawberry BENZALKONIUM CHLORIDE Quest USA Corp 47d6574c-0d4c-392e-e063-6394a90a590f 2026-01-07 Warnings Exact identifier application number: M003 Biopure Antibacterial Hand Wipe Vallina Dream BENZALKONIUM CHLORIDE Quest USA Corp 47d7090d-036b-870b-e063-6394a90a80c3 2026-01-07 Warnings Exact identifier application number: M003 99 Plus Hand Sanitizer BENZEALKONIUM CHLORIDE Momar Incorporated f972a8f1-c928-4e4b-a8dd-a2fb77052d21 2026-01-06 Warnings Exact identifier application number: M003 Benzocaine BENZOCAINE Dynarex Corporation 6161e94c-7849-466e-8da3-a6f1b085bdf9 2026-01-06 Warnings Exact identifier application number: M003 Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent BENZALKONIUM CHLORIDE Quest USA Corp 47c105a8-7c76-9cde-e063-6294a90a9284 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER VANILLA ETHYL ALCOHOL Rejoice International Corp. 47c3c187-da54-7c3b-e063-6294a90af3ce 2026-01-06 Warnings Exact identifier application number: M003 SPA HAND SANITIZER CHAMPAGNE BLASH ETHYL ALCOHOL Rejoice International Corp. 47c5e9af-4ea8-fb39-e063-6394a90aa5ab 2026-01-06 Warnings Exact identifier application number: M003 Antiseptic Cleaning wipe ANTISEPTIC CLEANING WIPE SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d01ae-d99e-bce3-e063-6294a90a1a2d 2026-01-05 Warnings Exact identifier application number: M003 Povidone-lodine prep pad POVIDONE-LODINE PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 201545b8-0697-5601-e063-6394a90a12f4 2026-01-05 Warnings Exact identifier application number: M003 Sting Relief prep Pad STING RELIEF PREP PAD SHENZHEN BENLIJU BIO-TECH CO.,LTD 202c7b77-1a48-52a5-e063-6394a90a2eb2 2026-01-05 Warnings Exact identifier application number: M003 Skin Cleaning Care Wipes SKIN CLEANING CARE WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 203d7a95-65fe-ca65-e063-6294a90acc6e 2026-01-05 Warnings Exact identifier application number: M003 ANTISEPTIC CLEANSING WIPE(0.9% NACL) ANTISEPTIC CLEANSING WIPE(0.9% NACL) SHENZHEN BENLIJU BIO-TECH CO.,LTD 33e1c026-8a35-a47a-e063-6294a90a2406 2026-01-05 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes HAND SANITIZING WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 37487da6-4e0e-6625-e063-6394a90a0af1 2026-01-05 Warnings Exact identifier application number: M003 Hand wipes HAND WIPES SHENZHEN BENLIJU BIO-TECH CO.,LTD 39f3acca-7275-88ca-e063-6394a90ad1a2 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Vanilla Heaven ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a0781b-9b25-f04b-e063-6294a90ae7e5 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47a16397-dff3-7d79-e063-6394a90a040f 2026-01-05 Warnings Exact identifier application number: M003 IDOSWAB B ISOPROPYL ALCOHOL IDO PHARM 16d19630-b67a-f3e1-e063-6394a90a7429 2026-01-05 Warnings Exact identifier application number: M003 Sure Comfort Alcohol Prep Pads ISOPROPYL ALCOHOL IDO PHARM 27def94b-d3a6-18b7-e063-6394a90a22a6 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Lemon Lime ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeaae9-740d-a28a-e063-6294a90a6460 2026-01-05 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Calming Lavender ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47aeeef9-0eed-e7d0-e063-6394a90a6d31 2026-01-05 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