Aplicare Povidone-Iodine

Product NDC
52380-0026
11-digit product format
523800026
Labeler code
52380
Product ID
52380-0026_b8ce14ec-d885-1b6b-e053-2a95a90a0eb5
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aplicare Products, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1984-07-01
Marketing end
2022-07-01
Substance
POVIDONE-IODINE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52380-0026DDiscontinued by firm2026-10-05
excluded packagepackage52380-002652380-0026-1DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52380-0026-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52380-0026-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52380-0026-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52380-0026-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52380-0026-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52380-0026-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52380-0026-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52380-0026-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52380-0026-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52380-0026-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52380-0026-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52380-0026-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0026-1GM - Gram52380-0026a8a01fe2-1c2c-46bc-980f-b898cbb575c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE, INC.]8
IODINEACTIVE MOIETY9679TC07X4APLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE, INC.]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE, INC.]8
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4APLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3APLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE, INC.]8
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X46800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI200987A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L46800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V36800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA746800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RA2649-17 CONTINUOUS EPIDURAL 17G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R6800 PORTEX CENTRAL LINE DRESSING () KIT [SMITHS MEDICAL ASD, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-0026-1523800026011 g in 1 PACKET (52380-0026-1) 1 g1984-07-012022-07-01NoNoCurrent