FDA.reportPublic FDA data

NDC 0121-0899-05 - Naprosyn

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
0121-0899
Requested NDC
0121-0899-05
Package NDCs from labels
0121-0899-05, 0121-0899-20
Manufacturer
Pharmaceutical Associates, Inc. | Entreprises Importfab, Inc.
Effective date
2020-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naprosyn - Pharmaceutical Associates, Inc. | Entreprises Importfab, Inc.Pharmaceutical Associates, Inc. | Entreprises Importfab, Inc.2020-12-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0899-202024-05-14C16284748780-1d6a99b39-66f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use NAPROSYN SUSPENSION safely and effectively. See full prescribing information for NAPROSYN SUSPENSION. NAPROSYN (naproxen) suspension, for oral use Initial U.S. Approval: 1976
0121-0899-202022-01-28C16284748780-1d6a99b39-66f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use NAPROSYN SUSPENSION safely and effectively. See full prescribing information for NAPROSYN SUSPENSION. NAPROSYN (naproxen) suspension, for oral use Initial U.S. Approval: 1976

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 64 · 1,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
NaproxenNAPROXENBryant Ranch Prepackf18181f4-6b14-48a8-a149-e45b3360a2502026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NaproxenNAPROXENCameron Pharmaceuticals2ae474dd-eaae-4401-8d42-613d672daea02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
NaproxenNAPROXENREMEDYREPACK INC.12202ef3-c65e-45a6-88ed-5d945d8fd41c2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LP5fd008ef-8388-48e9-8d38-76e0106bd5b62026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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