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 15 of 121 · 2,406 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC771d7fd8-184f-48a3-90ed-e8f00159d97e2026-05-18WarningsExact identifier
unii: 04JA59TNSJ
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c2026-05-15WarningsExact identifier
unii: 04JA59TNSJ
good neighbor pharmacy cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergenda91e6b6-32ff-44fd-afce-33ea9549554b2026-05-15WarningsExact identifier
unii: 04JA59TNSJ
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
unii: 04JA59TNSJ
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: 04JA59TNSJ
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
unii: 04JA59TNSJ
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
unii: 04JA59TNSJ
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Mucinex Fast-Max Cold and FluACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc16253d3-3824-458c-8840-e3a2fbe7682c2026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Fast-Max Severe Congestion and CoughGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1991d5ee-fc90-4070-8965-cd6f4abc45cf2026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa25278bd-c3b9-4db3-b4f7-b395eb5f91772026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa3523aa3-9ed1-472d-9986-438440d0a3eb2026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Nightshift SinusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC6189fb89-a7d7-4ae6-a9e8-d9512acc0f552026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC1e243dbe-138f-4346-ba22-ceea01e970522026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Nightshift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa14bc0d1-9b05-4a21-aaa8-95d4d073b9ed2026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Sinus-Max Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC128f3442-9802-4303-80be-aead092379362026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Sinus-Max Severe Congestion and Pain, Maximum StrengthACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2c01962d-74e3-4dfa-b7cb-a91a687711d52026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCf5365c6d-9296-41a5-953a-d1008954e67f2026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8905706b-b9da-4520-8cf2-87d7c125edf32026-05-13WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCfdb5c937-c148-eb46-e053-6394a90a8bed2026-05-13WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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