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 41 of 121 · 2,406 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DayTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe0f43-b92a-f947-e063-6394a90ab72c2025-12-10WarningsExact identifier
unii: 04JA59TNSJ
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
unii: 04JA59TNSJ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
unii: 04JA59TNSJ
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
unii: 04JA59TNSJ
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCbf264b20-6d00-495e-90c7-9172d4535ec72025-12-08Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
unii: 04JA59TNSJ
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpd0dd4a75-da65-4c66-b65f-54ee141008462025-12-05WarningsExact identifier
unii: 04JA59TNSJ
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
unii: 04JA59TNSJ
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
unii: 04JA59TNSJ
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
unii: 04JA59TNSJ
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact identifier
unii: 04JA59TNSJ
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast FizzCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.bd97e91f-1ae1-379c-e053-2995a90acfdd2025-12-04WarningsExact identifier
unii: 04JA59TNSJ
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a6a2dd4a-a3c8-2dfa-e053-2995a90ada862025-12-04WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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