FDA.reportPublic FDA data

NDC 70069-591-01 - 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
70069-591
Requested NDC
70069-591-01
Package NDCs from labels
70069-591-01, 70069-591-10
Manufacturer
Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited
Effective date
2025-03-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenylephrine Hydrochloride - Somerset Therapeutics, LLC | Somerset Therapeutics Private LimitedSomerset Therapeutics, LLC | Somerset Therapeutics Private Limited2025-03-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-591-01Phenylephrine Hydrochloride5 mL in 1 AMPULESOLUTION57
70069-591-10Phenylephrine Hydrochloride10 in 1 CARTONSOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-591PHENYLEPHRINE HYDROCHLORIDE SOLUTION [SOMERSET THERAPEUTICS, LLC]7Current NDC, 2 package rows20250306_170e63f1-23f4-4839-ab89-b81832d94a56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-591-01ML - Milliliter70069-591f273d1be-f3df-418b-9657-fee8baad1d2512025-10-14
70069-591-10ML - Milliliter70069-591554a221f-8efa-45ff-9338-fc8a2ce8678212025-10-14

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 81 of 118 · 2,341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Multi-Symptom NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.ce573785-f77d-4314-9b7a-ef3f1f4f34d82024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a3dcc-45b4-4093-e053-2995a90a3b142024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a7cc5-bd0e-b92b-e053-2995a90af50a2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Leader HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderc4814524-0f4c-4351-a431-5b4b6431fd282024-10-23WarningsExact identifier
unii: 04JA59TNSJ
basic care hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmazon.com Services LLC617d9213-31f0-4c71-be0c-7961b96e51432024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Signature Care HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLSafewaye74b71a1-915d-4e5b-b548-d5cce7945dbd2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
Equaline HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFId29b7824-ff9e-4875-b3de-92721c8add0e2024-10-23WarningsExact identifier
unii: 04JA59TNSJ
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: 451W47IQ8X
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc9d82968-b2ec-2f4b-e053-2a95a90a7f0c2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterb9d9ab99-44b1-455f-a29a-95c193a4808e2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb96c376e-578f-1124-e053-2a95a90acbb42024-10-22WarningsExact identifier
unii: 04JA59TNSJ
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc92b508b-e5f9-4149-8c4b-d21845943b3b2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb2091281-a64a-190a-e053-2995a90a890a2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPublix Super Markets Inca241cb37-7007-4fd8-a12e-f3fc6d6f780e2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: 451W47IQ8X
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLKroger Companyd44ca22a-dc20-454d-99aa-403a8c7a3e002024-10-22WarningsExact identifier
unii: 04JA59TNSJ
rugby hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLRugby Laboratoriesc1a126b5-0d34-437f-a7ef-8d5cbeb7b03b2024-10-22WarningsExact identifier
unii: 04JA59TNSJ
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 451W47IQ8X
Tukol Honey Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAc9572b16-8e28-4f98-bd87-8a07721a49c62024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEHEBa6cdc084-c23b-e733-e053-2995a90a35062024-10-21WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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