FDA.reportPublic FDA data

NDC 71863-203-01 - Biorphen

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
71863-203
Requested NDC
71863-203-01
Package NDCs from labels
71863-203-01, 71863-203-02
Manufacturer
Eton Pharmaceuticals, Inc. | SINTETICA SA
Effective date
2022-08-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Biorphen - Eton Pharmaceuticals, Inc. | SINTETICA SAEton Pharmaceuticals, Inc. | SINTETICA SA2022-08-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71863-203-01Biorphen1 mL in 1 AMPULEINJECTION, SOLUTION111
71863-203-02Biorphen10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-203BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [ETON PHARMACEUTICALS, INC.]11Legacy NDC, 2 package rows20220831_bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2.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 85 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: 451W47IQ8X
CareOne Fast Acting NasalPHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company95b22dce-ef54-4ab5-9cc3-0e1cefa09ec52024-10-24WarningsExact identifier
unii: 04JA59TNSJ
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Consortium, LLC8cb0d0c8-c565-4c5a-97c5-8250a67e23a82024-10-24WarningsExact identifier
unii: 04JA59TNSJ
CV HPADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),ENERGIQUE, INC.c06763c5-8bde-4251-bd41-67becf8ce8c42024-10-24WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.2af0dc7b-5f8b-44fa-9589-bc95043428e92024-10-24WarningsExact identifier
unii: 451W47IQ8X
rexall hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLDolgencorp Inc0415c51b-5a12-49d4-8968-0131ddb855452024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Exchange Select HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLArmy & Air Force Exchange Service8155ed74-9412-498f-998c-4a29c46e934f2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2325f33-e4e4-1269-e053-2995a90ab4ac2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a8240d98-f0b0-3ded-e053-2a95a90a5cf92024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a82401f5-65b1-11e9-e053-2a95a90a499e2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a823db21-4863-45a6-e053-2995a90ab8e62024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2346d0c-75cf-974c-e053-2a95a90a28572024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold Multi-Symptom NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.ce573785-f77d-4314-9b7a-ef3f1f4f34d82024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a3dcc-45b4-4093-e053-2995a90a3b142024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a7cc5-bd0e-b92b-e053-2995a90af50a2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Leader HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderc4814524-0f4c-4351-a431-5b4b6431fd282024-10-23WarningsExact identifier
unii: 04JA59TNSJ
basic care hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmazon.com Services LLC617d9213-31f0-4c71-be0c-7961b96e51432024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Signature Care HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLSafewaye74b71a1-915d-4e5b-b548-d5cce7945dbd2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Equaline HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFId29b7824-ff9e-4875-b3de-92721c8add0e2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
NITROGENNITROGENIndiana Oxygen Company Inc68349b39-b874-4df5-813a-8633c12787ce2024-10-23Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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