FDA.reportPublic FDA data

NDC 68083-465-01 - phenylephrine hydrochloride

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
68083-465
Requested NDC
68083-465-01
Package NDCs from labels
68083-465-01, 68083-465-25
Manufacturer
Gland Pharma Limited
Effective date
2021-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
phenylephrine hydrochloride - Gland Pharma LimitedGland Pharma Limited2021-04-14Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-465-01Phenylephrine HydrochloridePhenylephrine Hydrochloride1 mL in 1 VIALINJECTION18
68083-465-25Phenylephrine HydrochloridePhenylephrine Hydrochloride25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-465PHENYLEPHRINE HYDROCHLORIDE INJECTION PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [GLAND PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20210415_6486d284-5189-4000-aa7d-67150e84a7b2.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 34 of 121 · 2,419 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Promethazine and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
BACTIMICINA COUGH AND COLDDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDLC Laboratories, Inc.2e612c62-9bbb-45f2-a253-aa2bfaeaac702026-01-07WarningsExact identifier
unii: 04JA59TNSJ
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
unii: 04JA59TNSJ
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
unii: 04JA59TNSJ
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
unii: 04JA59TNSJ
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: 04JA59TNSJ
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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