Saninta 10% Povidone-Iodine

Product NDC
68356-601
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

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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui797730

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

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
68356-601-01683560601013 APPLICATOR in 1 POUCH (68356-601-01) / 2.3 mL in 1 APPLICATOR3 applicator2024-02-26NoNoCurrent
68356-601-026835606010222.5 mL in 1 PACKET (68356-601-02) 22.5 ml2024-02-26NoNoCurrent
68356-601-036835606010315 mL in 1 PACKET (68356-601-03) 15 ml2024-11-14NoNoCurrent