FDA.reportPublic FDA data

Prevail One Step

Product NDC
57613-008
11-digit product format
576130008
Labeler code
57613
Product ID
57613-008_a4da2a32-9713-4399-9e94-b8ff602dc818
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine and alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
CareFusion 2200 Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1997-06-01
Marketing end
2021-04-30
Substance
POVIDONE-IODINE; ALCOHOL
Active strength
5 mg/mL; mL/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57613-008DDiscontinued by firm2026-07-31
excluded packagepackage57613-00857613-008-59DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
ALCOHOLACTIVE MOIETY3K9958V90MPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
IODINEACTIVE MOIETY9679TC07X4PREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
NONOXYNOL-10INACTIVE INGREDIENTK7O76887APPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6
WATERINACTIVE INGREDIENT059QF0KO0RPREVAIL ONE STEP (POVIDONE-IODINE AND ALCOHOL) GEL [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57613-008-59576130008591 APPLICATOR in 1 POUCH (57613-008-59) > 59 mL in 1 APPLICATOR1 applicator1997-06-012021-04-30NoNoCurrent