Application 019382

Type
NDA
Sponsor
CLINIPAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001E-Z PREPPOVIDONE-IODINESOLUTION;TOPICAL10%NoNo
002E-Z PREPPOVIDONE-IODINESPONGE;TOPICAL5%NoNo
003E-Z PREP 220POVIDONE-IODINESPONGE;TOPICAL5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019382-001E-Z PREPPOVIDONE-IODINE10%SOLUTION / TOPICAL1989-07-25
N019382-002E-Z PREPPOVIDONE-IODINE5%SPONGE / TOPICAL1989-07-25
N019382-003E-Z PREP 220POVIDONE-IODINE5%SPONGE / TOPICAL1989-07-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019382-002E-Z PREP5%SPONGE / TOPICAL1989-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019382-003E-Z PREP 2205%SPONGE / TOPICAL1989-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019382-001E-Z PREP10%SOLUTION / TOPICAL1989-07-258072bd15b7f6…

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsName fallback
generic name: POVIDONE-IODINE
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-07-14WarningsName fallback
generic name: POVIDONE-IODINE
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsName fallback
generic name: POVIDONE-IODINE
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsName fallback
generic name: POVIDONE-IODINE
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsName fallback
generic name: POVIDONE-IODINE
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
Povidone Iodine Solution First Aid AntisepticPOVIDONE-IODINENice-Pak Products, LLCc2f07152-d7fb-4b1f-be77-c94618d5abd62026-03-12Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEFamily Dollar Stores, Inc58157bc5-54ea-49f8-9f17-f0eeb57323952026-02-24Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE