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 46 of 62 · 1,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
unii: PDC6A3C0OX
Caladryl ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEBausch Health US, LLCfca6f08b-7fa0-4ae6-bce3-61f3bcae43322024-10-17WarningsExact identifier
unii: 88AYB867L5
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 88AYB867L5
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 4T6H12BN9U
unii: 2KR89I4H1Y
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Inc43486da5-6e8b-45c0-bd7e-cc2d8b28c5102024-10-16WarningsExact identifier
unii: 88AYB867L5
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
unii: 88AYB867L5
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTEDWHITE PETROLEUMUniversal Distribution Center LLC649e571f-0cd6-41e4-b31f-c818f94fb01d2024-10-15WarningsExact identifier
unii: 4T6H12BN9U
Target Up and Up Petroleum JellyWHITE PETROLATUMTARGET CORPORATIONbaeaf660-ac4f-1ebc-e053-2995a90ac0c12024-10-14WarningsExact identifier
unii: 4T6H12BN9U
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
unii: 4T6H12BN9U
Exchange Select First Aid Triple Anitbiotic Pain RelievingBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLArmy & Air Force Exchange Service1c7f1700-69c0-4a71-8bb0-a71e3082efeb2024-10-14WarningsExact identifier
unii: 88AYB867L5
antibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E B55fa94cb-7e1c-41bc-879a-5618a828f14a2024-10-14WarningsExact identifier
unii: 88AYB867L5
first aid antibiotic and pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer, Inc.f0892a30-8a88-44e8-ab04-0e87c12f9c442024-10-14WarningsExact identifier
unii: 88AYB867L5
triple antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Incd97a69e8-4058-4c77-b628-ad3e2b97a6202024-10-14WarningsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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