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 75 of 75 · 1,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar General Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEDOLGENCORP, LLC86b0bd7b-c31c-4c35-a5da-0deac9558abe2017-10-01WarningsExact identifier
unii: LAV5U5022Y
Stomach reliefBISMUTH SUBSALICYLATECVS53cf4590-a625-42f7-bd03-8401d08b64472017-08-08WarningsExact identifier
unii: 62TEY51RR1
Maximum strength Stomach ReliefBISMUTH SUBSALICYLATECVS75326a55-7cf3-411e-96a3-a6aef6c35ca52017-08-08WarningsExact identifier
unii: 62TEY51RR1
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
ParathyroplexPARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEABioActive Nutritional, Inc.37649bb9-cbd7-4971-b410-18ea307c46f62017-04-18WarningsExact identifier
unii: ETJ7Z6XBU4
Arthritis JointsGNAPHALIUM POLYCEPHALUM, BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, BORAX, CUPRUM ACETICUM, KALI CARBONICUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, AMMONIUM MURIATICUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, GLANDULA SUPRARENALIS SUIS, MERCURIUS PRAECIPITATUS RUBER, SEPIA, ZINCUM METALLICUM, PALLADIUM METALLICUM, PICRICUM ACIDUM, SULPHUR, CARTILAGO SUIS, INTERVERTEBRAL DISC (SUIS), MEDULLA OSSIS SUISDeseret Biologicals, Inc.cec46d33-e106-481a-958d-b2aedabe18792017-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: ETJ7Z6XBU4
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
unii: 62TEY51RR1
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

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