FDA.reportPublic FDA data

NDC 80587-181-01 - 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
Requested NDC
80587-181-01
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 8 of 62 · 1,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
unii: 4T6H12BN9U
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
unii: 88AYB867L5
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 88AYB867L5
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
unii: 4T6H12BN9U
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
unii: 88AYB867L5
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
unii: 2KR89I4H1Y
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
WELL AT WALGREENS BABY ADVANCED HEALINGPETROLATUMWALGREEN COMPANY75067953-4cd8-4fcb-b7b7-dd0d2200642d2026-05-05WarningsExact identifier
unii: 4T6H12BN9U
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
unii: 4T6H12BN9U
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
unii: 4T6H12BN9U
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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