FDA.reportPublic FDA data

NDC 80587-181 - PRAX

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
80587-181
Package NDCs from labels
80587-181-01
Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAX - Prime Labs LLC dba Quality CDMOPrime Labs LLC dba Quality CDMO2025-11-19HUMAN OTC DRUG LABEL

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 59 of 62 · 1,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack0c28458a-cc56-4eea-89aa-d60659bd95682023-08-17Adverse reactionsExact identifier
unii: 88AYB867L5
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
unii: 88AYB867L5
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
unii: 4T6H12BN9U
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack2f036f41-93b9-4653-b24b-6fadf6fae4e42023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepackc79ca385-5fff-4d86-a8b2-098d3e0aa8fa2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack79fae74b-bef2-4e13-a2e9-da68747951eb2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack2c74c1c8-91c7-4468-9b1a-7217834311962023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack3c5e1833-9908-4e4f-bdf2-7a28c14a585c2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: PDC6A3C0OX
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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