FDA.reportPublic FDA data

NDC 70069-802-01 - 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
70069-802
Requested NDC
70069-802-01
Package NDCs from labels
70069-802-01, 70069-802-10
Manufacturer
Somerset Therapeutics, LLC | Caplin Steriles Limited
Effective date
2021-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENYLEPHRINE - Somerset Therapeutics, LLC | Caplin Steriles LimitedSomerset Therapeutics, LLC | Caplin Steriles Limited2021-09-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-802-01PHENYLEPHRINE HYDROCHLORIDE5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION51
70069-802-10PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-802PHENYLEPHRINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]1Current NDC, Legacy NDC, 2 package rows20210923_90a3853e-49d6-4536-be72-82cc875bcf74.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-802-01ML - Milliliter70069-80262e65251-156c-48ac-a38a-e2310386c46c12021-11-09
70069-802-10ML - Milliliter70069-802d1f09790-fad7-4e76-8ab5-bc9b856e2cc612021-11-09

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 98 of 121 · 2,419 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
unii: 04JA59TNSJ
Theraflu PowerPods Daytime Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCe655c33c-c319-41d9-ae55-cf747242cd102024-03-08WarningsExact identifier
unii: 04JA59TNSJ
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: 451W47IQ8X
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCf6ae9e3a-6bea-40e0-8a6f-45f4be8319e72024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb2024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC62f7fcb9-e31a-4634-b1c2-44a9567e3a612024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Theraflu ExpressMax Severe Cold and Flu CapletsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC8e22f6bc-33ce-4bb0-99be-7947aa21f60e2024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Theraflu ExpressMax Severe Cold and Flu SyrupACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC777d2ac7-e3cc-4513-8b6f-b90b2ff2c6722024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy4c6025ff-4982-4408-b077-75dd5f5b65b22024-03-07WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacy423fd5e6-5d90-4539-81e0-0ae23881ee3a2024-03-07WarningsExact identifier
unii: 04JA59TNSJ
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2022-2023), MORBILLINUMDeseret Biologicals, Inc.ce3962de-576a-49f6-8dc3-68ba7ad96e9f2024-03-05WarningsExact identifier
unii: 451W47IQ8X
Multi-Symptom Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)3c7ef3cf-f7f9-42bc-bf20-e36954b9671f2024-03-05WarningsExact identifier
unii: 04JA59TNSJ
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: QTT17582CB
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: 451W47IQ8X
PREPARATION HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa23ded81-78ba-c199-a8f0-aaf360b216ff2024-03-02WarningsExact identifier
unii: 04JA59TNSJ
QUALITY CHOICE NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.da06e994-6848-4c1e-9432-31de5e626ea42024-03-02WarningsExact identifier
unii: 04JA59TNSJ
QUALITY CHOICE DayTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.417c4fa9-6458-40d0-b22a-2415194e250f2024-03-02WarningsExact identifier
unii: 04JA59TNSJ
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAurohealth LLC8eaa0eec-cc52-4f1f-8ddb-06c54d577ce22024-03-01WarningsExact identifier
unii: 04JA59TNSJ
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
unii: 04JA59TNSJ
Preparation H Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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