FDA.reportPublic FDA data

Loris Povidone-Iodine

Product NDC
68356-119
11-digit product format
683560119
Labeler code
68356
Product ID
68356-119_e9bdeac8-1bf5-b510-e053-2a95a90a089c
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
LIQUID
Route
TOPICAL
Labeler
LernaPharm Loris Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-13
Marketing end
0000-00-00
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68356-119DDiscontinued by firm2026-10-05
excluded packagepackage68356-11968356-119-01DDiscontinued by firm2026-10-05
excluded packagepackage68356-11968356-119-02DDiscontinued by firm2026-10-05
excluded packagepackage68356-11968356-119-03DDiscontinued by firm2026-10-05
excluded packagepackage68356-11968356-119-06DDiscontinued by firm2026-10-05
excluded packagepackage68356-11968356-119-07DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0568356-119-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568356-119-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568356-119-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2668356-119-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668356-119-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668356-119-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3168356-119-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168356-119-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168356-119-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2868356-119-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868356-119-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868356-119-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2168356-119-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168356-119-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168356-119-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1068356-119-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068356-119-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068356-119-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3168356-119-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168356-119-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168356-119-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2068356-119-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068356-119-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068356-119-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1068356-119-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068356-119-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068356-119-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0868356-119-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868356-119-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868356-119-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0368356-119-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368356-119-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368356-119-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0968356-119-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968356-119-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968356-119-06557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MLORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
IODINEACTIVE MOIETY9679TC07X4LORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TLORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74LORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RLORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68356-119LORIS POVIDONE-IODINE SOLUTION (POVIDONE-IODINE) LIQUID [LERNAPHARM LORIS INC.]8Legacy NDC20231022_7a1ba66a-e5be-415f-8aee-c132330836d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68356-119-01683560119013 APPLICATOR in 1 POUCH (68356-119-01) > 2.5 mL in 1 APPLICATOR3 applicator2013-04-160000-00-00NoNoCurrent
68356-119-026835601190222.5 mL in 1 POUCH (68356-119-02) 22.5 ml2013-04-160000-00-00NoNoCurrent
68356-119-03683560119031 APPLICATOR in 1 POUCH (68356-119-03) > 2.5 mL in 1 APPLICATOR1 applicator2017-07-140000-00-00NoNoCurrent
68356-119-06683560119062.6 mL in 1 PACKET (68356-119-06) 2.6 ml2017-07-140000-00-00NoNoCurrent
68356-119-07683560119072.6 mL in 1 PACKET (68356-119-07) 2.6 ml2017-07-140000-00-00NoNoCurrent