FDA.reportPublic FDA data

NDC 57319-393 - Corrective

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57319-393
Package NDCs from labels
57319-393-09
Manufacturer
Phoenix Pharmaceutical Inc./ Clipper Distributing, Inc.
Effective date
2013-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Corrective Suspension Anti-Diarrheal SuspensionPhoenix Pharmaceutical Inc./ Clipper Distributing, Inc.2013-09-17OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-393-09Corrective3785 mL in 1 BOTTLESUSPENSION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-393CORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]21 package rows20130917_3d1c67bf-21ef-44f9-b0b3-2e8be0c5fd7d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1CORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YECORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
GUAR GUMINACTIVE INGREDIENTE89I1637KECORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YCORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCORRECTIVE (BISMUTH SUBSALICYLATE) SUSPENSION [PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.]2

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 20 of 75 · 1,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
unii: LAV5U5022Y
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
unii: LAV5U5022Y
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
unii: LAV5U5022Y
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL7-Eleven5625ac4e-aa37-41b5-80b7-67b223707ccf2026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAldi, Inc08aef3fa-f863-4716-ac72-1d7bfcc0d6ef2026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC498cd2aa-ee59-67b5-e063-6294a90ac2422026-01-29WarningsExact identifier
unii: LAV5U5022Y
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAMERISOURCE BERGEN02ffe892-732b-4798-9ea8-ca646c37f3002026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCardinal Health, 110 dba Leaderd176eebb-4870-4206-a52e-f581ecaff4002026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International4ca91b34-a3ba-4c23-8bfb-473342ac42a22026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International98471185-3798-412f-b9b4-47f1971fbc7c2026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International035e82fc-75eb-474d-88ce-771e60e621792026-01-29Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Bismuth subsalicylateBISMUTH SUBSALICYLATESoftgel Healthcare Pvt Ltd18f59606-1498-bd0c-e063-6394a90a7df22026-01-27WarningsExact identifier
unii: 62TEY51RR1
PAINREUSEABLE PAINShenzhen Mengyue Technology Co., Ltd.44e058fc-e1c0-742b-e063-6294a90ad2252026-01-27WarningsExact identifier
unii: LAV5U5022Y
Velocx for Joint and Muscle Pain Roll-On ApplicatorMENTHOL, METHYL SALICYLATEJMAD Consulting LLC, dba JMAD Labsdbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d212026-01-26WarningsExact identifier
unii: LAV5U5022Y
Topcare Medicated Pain Relieving Patch 60ctTOPCARE PAIN RELIEF PATCH EXTRA STRENGTHTopco Associates LLC4953c12b-ca6d-d21e-e063-6294a90ac9902026-01-26WarningsExact identifier
unii: LAV5U5022Y
THE GOO MEDICATED PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAPSM PERFORMANCE, LLCdb4c321c-8cdc-5a11-e053-2995a90a91a12026-01-23WarningsExact identifier
unii: LAV5U5022Y
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
unii: LAV5U5022Y
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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