Povidone-iodine prep pad

Product NDC
80514-002
Requested package NDC
80514-002-01
11-digit product format
805140002
Labeler code
80514
Product ID
80514-002_ae6059b7-91f4-3274-e053-2a95a90acb37
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-09-04
Marketing end
0000-00-00
Substance
POVIDONE-IODINE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80514-00280514-002-01IInactivated by FDA2026-10-12

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80514-002-012025-01-30C16284748780-12cef2736-8c53-d83d-e063-dadaa90ab31fae606094-7085-2247-e053-2a95a90afc9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80514-002-01Povidone-iodine prep pad0.5 g in 1 POUCHSWAB0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80514-002POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.]3Legacy NDC, 1 package rows20231226_ae606094-7085-2247-e053-2a95a90afc9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNae606094-7085-2247-e053-2a95a90afc9d3
797730povidone-iodine 100 MG/ML Medicated PadSCDae606094-7085-2247-e053-2a95a90afc9d3
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYae606094-7085-2247-e053-2a95a90afc9d3
797730povidone-iodine 10 % Medicated PadSYae606094-7085-2247-e053-2a95a90afc9d3
797730povidone-iodine 10 % Medicated SwabstickSYae606094-7085-2247-e053-2a95a90afc9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80514-002-0180514000201.5 g in 1 POUCH (80514-002-01) 2020-09-040000-00-00NoNoCurrent