FDA.reportPublic FDA data

NDC 61354-030-01 - Cream

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
61354-030
Requested NDC
61354-030-01
Package NDCs from labels
61354-030-02, 61354-030-04, 61354-030-03, 61354-030-05, 61354-030-01, 61354-030-06
Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL
Cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61354-030-042025-01-302cef2736-6980-d83d-e063-dadaa90ab31fKYPRIS POT OF SHADE HELIOTROPIC SPF 30 UVA+UVB SUNSCREEN PROTECTION SOLAIRE PRIMER
61354-030-052025-01-302cef2736-6980-d83d-e063-dadaa90ab31fKYPRIS POT OF SHADE HELIOTROPIC SPF 30 UVA+UVB SUNSCREEN PROTECTION SOLAIRE PRIMER
61354-030-062025-01-30f386c649-d6d8-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC PRIME AND PROTECT BROAD SPECTRUM SPF 30
61354-030-062023-02-10f386c649-d6d8-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC PRIME AND PROTECT BROAD SPECTRUM SPF 30
61354-030-062023-01-30f386c649-d6d8-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC PRIME AND PROTECT BROAD SPECTRUM SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-030-02Cream68 mg in 1 JARCREAM683
61354-030-03Cream27 mg in 1 JARCREAM273
61354-030-04Cream1 in 1 CARTONCREAM13
61354-030-05Cream1 in 1 CARTONCREAM13
61354-030-01Cream3 mg in 1 JARCREAM32
61354-030-06Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-030CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 4 package rows20230211_bbefaa50-1071-7a45-e053-2995a90a7df3.zip
61354-030CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bbf2f00b-fb95-7f3b-e053-2995a90a4e8b.zip

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 240 of 282 · 5,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: SOI2LOH54Z
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: SOI2LOH54Z
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
unii: SOI2LOH54Z
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: SOI2LOH54Z
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: SOI2LOH54Z
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
unii: 451W47IQ8X
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15OCTINOXATE, OCTISALATE, AND ZINC OXIDEGuthy-Renker LLC6437fbf6-c84b-497e-bf69-b20153d4c7062024-01-11WarningsExact identifier
unii: SOI2LOH54Z
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
unii: SOI2LOH54Z
Principal Secret Reclaim Sunscreen For Face and Body SPF 30MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDEGuthy-Renker LLC4a183aa2-deda-4b26-a126-6f98cfbdb0f32024-01-10WarningsExact identifier
unii: SOI2LOH54Z
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: SOI2LOH54Z
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: 451W47IQ8X
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: 451W47IQ8X
A05 HEAVY ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUMApex Energetics Inc.b9bdc39e-8ebf-615c-e053-2a95a90afe1b2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
B07 DPRSN ANTITOXADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWERApex Energetics Inc.bd1fbb76-4f6f-7098-e053-2a95a90ae25c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
B13 CELL SALT COMPLEXALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENSApex Energetics Inc.bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d2024-01-08WarningsExact identifier
unii: 451W47IQ8X
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: PDC6A3C0OX
F01 ANGR-RLSBIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CHAMOMILE FLOWER, CHICORY FLOWER, GARLIC, ENGLISH HOLLY FLOWER, EUROPEAN BEECH FLOWER, FORKING LARKSPUR FLOWER, GERMAN CHAMOMILE FLOWER, IMPATIENS GLANDULIFERA FLOWER, LILIUM TIGRINUM, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, RUBBER RABBITBRUSH, VITIS VINIFERA FLOWER, WATERMELON, WHITE WILLOW FLOWER, YELLOW STAR THISTLEApex Energetics Inc.bd0b2eab-b6eb-19ce-e053-2a95a90aebe62024-01-08WarningsExact identifier
unii: 451W47IQ8X
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
D05 KDNY-DRNAPIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAFApex Energetics Inc.146800dc-bb1a-4d4c-803a-156a9fba600d2024-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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