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 189 of 287 · 5,722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOS Face Guard Broad Spectrum Sunscreen SPF 30ZINC OXIDETower 286687006a-bd79-4e1c-a546-0f0b51b299482025-01-28WarningsExact identifier
unii: SOI2LOH54Z
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230OCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb1a767-3228-71ea-e063-6294a90ac89e2025-01-27WarningsExact identifier
unii: SOI2LOH54Z
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cb77125-ff77-2060-e063-6294a90ab69f2025-01-27WarningsExact identifier
unii: SOI2LOH54Z
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: SOI2LOH54Z
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: SOI2LOH54Z
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
unii: SOI2LOH54Z
Equate Sterile Saline MistSODIUM CHLORIDEWALMART INC.275ada29-8904-fe1e-e063-6394a90abe592025-01-24WarningsExact identifier
unii: 451W47IQ8X
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: SOI2LOH54Z
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: SOI2LOH54Z
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
unii: SOI2LOH54Z
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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