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 35 of 75 · 1,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
unii: LAV5U5022Y
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
unii: LAV5U5022Y
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
unii: LAV5U5022Y
Listerine Gum Therapy Mouthwash Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC40a0bdf3-1698-1449-e063-6394a90ab13d2025-10-08WarningsExact identifier
unii: LAV5U5022Y
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
unii: LAV5U5022Y
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
unii: LAV5U5022Y
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
unii: LAV5U5022Y
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
unii: LAV5U5022Y
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
unii: LAV5U5022Y
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
unii: LAV5U5022Y
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
unii: LAV5U5022Y
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
unii: LAV5U5022Y
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
unii: LAV5U5022Y
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
unii: LAV5U5022Y
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
unii: LAV5U5022Y
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
unii: LAV5U5022Y
Methyl Salicylate 40% Topical OilMETHYL SALICYLATEFORREAL PHARMACEUTICALS LLC10e15734-9783-4153-b7b6-a4d0f57678b62025-10-07WarningsExact identifier
unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

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