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 53 of 124 · 2,470 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENRaimy Corporation9af1adde-4612-2b8d-e053-2a95a90a8c882025-10-30Exact identifier
unii: N762921K75
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incc7cef266-46fc-49ab-a2e7-54fc562986592025-10-30WarningsExact identifier
unii: 04JA59TNSJ
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
unii: 04JA59TNSJ
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLSAFEWAY013b94a1-26c7-4371-981a-d1b9d7fd1c982025-10-29WarningsExact identifier
unii: 04JA59TNSJ
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
unii: 04JA59TNSJ
NitrogenNITROGENILMO Products Company7e0f2f4a-ac52-412c-97c6-0b4c44bdb5a52025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGEN801576526754a7d13-973f-42ed-87fa-3ef5d5f90bec2025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENGeer Gas Corporation98bf51e7-01bb-e3f7-e053-2995a90a42f02025-10-29Exact identifier
unii: N762921K75
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENJ & M CYLINDER GASES, INC.9af277a4-04f6-0805-e053-2a95a90a78c82025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENToll Company07dcb683-a5e9-b016-e063-6394a90a746d2025-10-29Exact identifier
unii: N762921K75
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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