FDA.reportPublic FDA data

Saninta 10% Povidone-Iodine

Product NDC
68356-601
Requested package NDC
68356-601-03
11-digit product format
683560601
Labeler code
68356
Product ID
68356-601_26edf53b-4ba3-a69b-e063-6294a90a1769
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine Solution
Dosage form
LIQUID
Route
TOPICAL
Labeler
Lernapharm
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-26
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Saninta 10% Povidone-Iodine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1275efa3-0602-2f17-e063-6394a90ac56eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68356-601-01Saninta 10% Povidone-Iodine2.3 mL in 1 APPLICATORLIQUID2.32
68356-601-01Saninta 10% Povidone-Iodine3 in 1 POUCHLIQUID32
68356-601-02Saninta 10% Povidone-Iodine22.5 mL in 1 PACKETLIQUID22.52
68356-601-03Saninta 10% Povidone-Iodine15 mL in 1 PACKETLIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68356-601SANINTA 10% POVIDONE-IODINE (POVIDONE-IODINE SOLUTION) LIQUID [LERNAPHARM]2Current NDC, 4 package rows20241116_1275efa3-0602-2f17-e063-6394a90ac56e.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Saninta 10% Povidone-IodinePOVIDONE-IODINE SOLUTIONLernapharm1275efa3-0602-2f17-e063-6394a90ac56e2024-11-15WarningsExact identifier
ndc (package): 68356-601-03
ndc (product): 68356-601
ndc11 (package): 68356060103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN1275efa3-0602-2f17-e063-6394a90ac56e2
797730povidone-iodine 100 MG/ML Medicated PadSCD1275efa3-0602-2f17-e063-6394a90ac56e2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY1275efa3-0602-2f17-e063-6394a90ac56e2
797730povidone-iodine 10 % Medicated PadSY1275efa3-0602-2f17-e063-6394a90ac56e2
797730povidone-iodine 10 % Medicated SwabstickSY1275efa3-0602-2f17-e063-6394a90ac56e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68356-601-036835606010315 mL in 1 PACKET (68356-601-03) 15 ml2024-11-14NoNoCurrent