FDA.reportPublic FDA data

NDC 51596-004-01 - Upset Stomach Relief to Go

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
51596-004
Requested NDC
51596-004-01
Package NDCs from labels
51596-004-01, 51596-004-05, 51596-004-12, 51596-004-24, 51596-004-10
Manufacturer
Breakthrough Products Inc.
Effective date
2014-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Upset Stomach Relief to Go ™Breakthrough Products Inc.2014-10-08HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51596-004-05Upset Stomach Relief to Go ™
51596-004-10Upset Stomach Relief to Go ™
51596-004-12Upset Stomach Relief to Go ™
51596-004-24Upset Stomach Relief to Go ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51596-004-01Upset Stomach Relief to Go1 in 1 POUCHPOWDER14
51596-004-05Upset Stomach Relief to Go5 in 1 BOXPOWDER54
51596-004-10Upset Stomach Relief to Go1 in 1 PACKETPOWDER14
51596-004-10Upset Stomach Relief to Go10 in 1 BOXPOWDER104
51596-004-12Upset Stomach Relief to Go12 in 1 BOXPOWDER124
51596-004-24Upset Stomach Relief to Go24 in 1 BOXPOWDER244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51596-004UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4Legacy NDC, 6 package rows20141017_a019eedf-073d-43c6-ad30-dedb9dd51fbd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bismuth subsalicylateACTIVE INGREDIENT62TEY51RR1UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEUPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLUPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4
dextroseINACTIVE INGREDIENTIY9XDZ35W2UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]4

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 46 of 46 · 906 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
b34d453b-5109-4fbe-b4d6-78f8b0dde776a019eedf-073d-43c6-ad30-dedb9dd51fbd2014-10-08WarningsExact identifier
spl id: b34d453b-5109-4fbe-b4d6-78f8b0dde776
spl set id: a019eedf-073d-43c6-ad30-dedb9dd51fbd
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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