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 84 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Instant Hand Sanitizer INSTANT HAND SANITIZER Raining Rose, Inc 2f37a2a1-5250-4052-e063-6294a90aef7f 2025-02-28 Warnings Exact identifier application number: M003 Signature Care Advanced Hand Sanitizer with Aloe ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. a20c821a-80d9-499c-aecd-3cf4d8e02590 2025-02-27 Warnings Exact identifier application number: M003 Signature Care Advanced Hand Sanitizer ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e 2025-02-27 Warnings Exact identifier application number: M003 Signature Care Advanced Hand Sanitizer with Aloe ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. f2309f34-a1ee-44c7-b818-7384de64d27b 2025-02-27 Warnings Exact identifier application number: M003 Signature Care Advanced Hand Sanitizer ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. dcfc08a0-ecd6-42d3-9ff2-e68d5317152f 2025-02-27 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL AmerisourceBergen (Good Neighbor Pharmacy) 46122 c47986e9-c851-491b-817e-fd3e0b054cd4 2025-02-26 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL AmerisourceBergen (Good Neighbor Pharmacy) 46122 00737139-bab8-40be-ad85-32526b5eab10 2025-02-26 Warnings Exact identifier application number: M003 AUM Alcohol Pad ALCOHOL PAD SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS 632da1b7-70bb-467d-81b2-39536f9fff3c 2025-02-26 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Universal Synergetics, Inc 0dd6884c-935f-4523-b19a-201b7a8666fc 2025-02-24 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Walgreens 78ed5594-433a-4f90-ad39-51e2a7dd2e21 2025-02-21 Warnings Exact identifier application number: M003 Isopropyl alcohol 70 percent ISOPROPYL ALCOHOL Walgreens 9effa6c9-020d-4a2d-ad26-449d4119b6a0 2025-02-21 Warnings Exact identifier application number: M003 Isopropyl alcohol 50 percent Wintergreen ReadyInCase ISOPROPYL ALCOHOL P & L Development, LLC f9ff67b0-c4ad-4162-b3ef-27a85ed0da25 2025-02-18 Warnings Exact identifier application number: M003 Inverness Home Ear Piercing Kit BENZALKONIUM CHLORIDE The Richline Group, Inc. 80909a34-21da-4c54-bb62-fd986fd24b04 2025-02-17 Warnings Exact identifier application number: M003 Inverness EAR CARE ANTISEPTIC BENZALKONIUM CHLORIDE The Richline Group ac42d2f1-69e3-45f6-8002-d45ebed5ee22 2025-02-17 Warnings Exact identifier application number: M003 Licensed Hand Sanitizer Barbie 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2e1507f1-a88f-4ef8-e063-6294a90a92fd 2025-02-14 Warnings Exact identifier application number: M003 Licensed Hand Sanitizer Hot Wheels 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2e159f8f-352c-45ca-e063-6394a90adf9b 2025-02-14 Warnings Exact identifier application number: M003 Licensed Hand Sanitizer Crayola 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2e1633f1-4b59-6eea-e063-6294a90ae61b 2025-02-14 Warnings Exact identifier application number: M003 Licensed Hand Sanitizer Spider man 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 2e16c9bc-223d-0c65-e063-6294a90a4815 2025-02-14 Warnings Exact identifier application number: M003 Betadine POVIDONE-IODINE Atlantis Consumer Healthcare, Inc. 3007da5f-e2ea-4f3a-905c-770782da014e 2025-02-14 Warnings Exact identifier application number: M003 50 percent Isopropyl alcohol ISOPROPYL ALCOHOL Whole Foods Market 6cb4ccca-96e7-43cb-ae05-95a411e71255 2025-02-14 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