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 102 of 122 · 2,436 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
unii: 04JA59TNSJ
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
unii: 04JA59TNSJ
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
unii: 04JA59TNSJ
RRHOID RAGE HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLCa02a6398-0acd-4aa7-8320-ac586ff12eb32024-01-31WarningsExact identifier
unii: 04JA59TNSJ
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
unii: 04JA59TNSJ
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
unii: 04JA59TNSJ
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
unii: 04JA59TNSJ
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
unii: 04JA59TNSJ
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
unii: 04JA59TNSJ
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
unii: 04JA59TNSJ
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 451W47IQ8X
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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