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 1 of 75 · 1,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: LAV5U5022Y
Medique Diotame InstydoseBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b214128-6980-0f84-e063-6294a90ad8ca2026-09-10WarningsExact identifier
unii: 62TEY51RR1
Regular Strength Pink BismuthBISMUTH SUBSALICYLATERaritan Pharmaceuticals Inc89d18117-f0af-408a-a5ae-19da841588062026-09-09WarningsExact identifier
unii: 62TEY51RR1
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.a03fabe0-4839-480e-8890-278e573cf4cc2026-09-09WarningsExact identifier
unii: 62TEY51RR1
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.5fa794f9-440c-479c-961c-34d298bb532b2026-09-09WarningsExact identifier
unii: 62TEY51RR1
DRx Choice Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERARITAN PHAMACEUTICALS INC75e8cd49-850f-4816-b350-ce76601ebfc02026-09-09WarningsExact identifier
unii: 62TEY51RR1
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporation90b0c541-2834-4ed7-9d01-76080dd730572026-09-09WarningsExact identifier
unii: 62TEY51RR1
Pepto Bismol Fast Melts Fresh Berry FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company039391d0-9ec1-45a3-84fa-b5f591794e412026-09-08WarningsExact identifier
unii: 62TEY51RR1
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Kroger Regular Strength Pink BismuthBISMUTH SUBSALICYLATEKROGER COMPANY97175691-4881-450d-a14c-3413ab47a3ca2026-09-02WarningsExact identifier
unii: 62TEY51RR1
Kroger Stomach ReliefBISMUTH SUBSALICYLATEKROGER COMPANY4963f568-9d8d-4ad0-b840-bed3f6f9cb7b2026-09-01WarningsExact identifier
unii: 62TEY51RR1
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: LAV5U5022Y
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: LAV5U5022Y
Ultra Strength digestive reliefBISMUTH SUBSALICYLATETHE KROGER CO.5e288108-1578-4379-a3d6-44b4471876432026-09-01WarningsExact identifier
unii: 62TEY51RR1
Kroger Digestive ReliefBISMUTH SUBSALICYLATEKROGER COMPANY2b32bee7-154a-4e5b-a811-066d1e6c5dcb2026-09-01WarningsExact identifier
unii: 62TEY51RR1
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: LAV5U5022Y
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.50a88db4-633d-d3bc-e063-6294a90a18c52026-08-29WarningsExact identifier
unii: 62TEY51RR1
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

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