FDA.reportPublic FDA data

NDC 72087-013-20 - Difixn

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
72087-013
Requested NDC
72087-013-20
Package NDCs from labels
72087-013-20, 72087-013-40
Manufacturer
Goldman Pharmaceutical Group Inc | Goldman Pharmaceutical Group, Inc.
Effective date
2019-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Difixn™Goldman Pharmaceutical Group Inc | Goldman Pharmaceutical Group, Inc.2019-04-22OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72087-013-20Difixn20 in 1 BOTTLETABLET201
72087-013-40Difixn40 in 1 BOTTLETABLET401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72087-013DIFIXN (LOPERAMIDE HYDROCHLORIDE) TABLET [GOLDMAN PHARMACEUTICAL GROUP INC]12 package rows20190510_efd14a74-447c-45fc-989a-01154f719f5d.zip

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 36 of 40 · 800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPae2e15e9-1707-296d-e053-2995a90a1b952022-11-01WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Pharmaceuticals Inc.72a7ae47-cdf3-4949-b9f8-f29b153f787f2022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
unii: 77TI35393C
Loperamide HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
unii: 77TI35393C
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCd1fd9a92-9d96-4921-b789-c1f710ee23512022-06-03WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid Corporation9cee17ca-bd11-3d40-e053-2995a90ac8fe2022-05-24WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLC1537febf-2816-438b-979a-8c8f16f06de52022-05-24WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEB3ea49be2-1744-4d14-bc43-09d35fd4b3c72022-05-19WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d69532c-c71a-4880-9f74-4b37d912cabd2022-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEProficient Rx LP82e65393-25b7-4114-9c71-5840ee8bad842022-05-02WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLC93ebbb23-a9f0-4519-9793-c9056be39f232022-03-22WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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