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 45 of 46 · 906 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
unii: 62TEY51RR1
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
unii: 62TEY51RR1
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
unii: 62TEY51RR1
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
Pepto ReliefBISMUTH SUBSALICYLATEAdvance Pharmaceutical Inc.a02babe7-9255-44c7-90e1-b5ad5e59c72a2017-12-22WarningsExact identifier
unii: 62TEY51RR1
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATECVS PHARMACY, INC.65dbe287-4528-4dbd-9116-6d4812fd4fa22017-11-28WarningsExact identifier
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATEPuraCap Pharmaceutical LLC01a4782f-93af-4d30-8ca3-7b39c272f60e2017-11-28WarningsExact identifier
unii: 62TEY51RR1
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
unii: 62TEY51RR1
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
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

Reported adverse events (FAERS/openFDA)#

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