Home NDC 52380-0101-5 Aplicare Povidone-Iodine Paint
Product NDC 52380-0101
Requested package NDC 52380-0101-5
11-digit product format 523800101
Labeler code 52380
Product ID 52380-0101_efe342f9-9a5c-b9b4-e053-2a95a90a3e00
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form SOLUTION
Route TOPICAL
Labeler Aplicare Products, LLC
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1992-03-01
Marketing end 2025-07-31
Substance POVIDONE-IODINE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52380-0101 52380-0101-5 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52380-0101 52380-0101-5 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POVIDONE-IODINE ACTIVE INGREDIENT 85H0HZU99M APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 IODINE ACTIVE MOIETY 9679TC07X4 APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 NONOXYNOL-9 INACTIVE INGREDIENT 48Q180SH9T APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52380-0101 APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC] 8 Legacy NDC 20221217_b66bb4d3-dccf-4fd6-a760-a0b2c22d56bb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52380-0101-5 52380010105 2 APPLICATOR in 1 PACKAGE (52380-0101-5) > 52.5 mL in 1 APPLICATOR 2 applicator 1992-03-01 2025-07-31 No No Current