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 56 of 124 · 2,470 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
unii: 04JA59TNSJ
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
unii: 04JA59TNSJ
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
unii: 04JA59TNSJ
NITROGENNITROGENFlint Welding Supply Company4bd47792-3465-488d-b4d7-eafd5c83807e2025-10-13Exact identifier
unii: N762921K75
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENWesco Gas & Welding Supply, Inc.ea2a3b5d-f53f-49cd-9e43-708f69879cce2025-10-13Exact identifier
unii: N762921K75
NitrogenNITROGENAli-Rob, Inc. dba Southern Oxygen & Welding Supply0a5ef7df-9c18-56a4-e063-6394a90ab3ad2025-10-13Exact identifier
unii: N762921K75
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
unii: 04JA59TNSJ
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
unii: 04JA59TNSJ
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
unii: 04JA59TNSJ
NitrogenNITROGENBill Munn Supply, Inc.780e7740-e37a-9e6d-e053-2991aa0a998d2025-10-09Exact identifier
unii: N762921K75
NitrogenNITROGENB & J Welding Supply, LTD. dba B & J Welding Supply4faa22a2-442c-4b2a-badc-c4e502493d082025-10-09Exact identifier
unii: N762921K75
NitrogenNITROGENJackson Welding Supply Co Inc.7c242f6e-06a9-44cd-8aec-2d90ece44f442025-10-09Exact identifier
unii: N762921K75
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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