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 267 of 282 · 5,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gyno ComplexVIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Incdfaaa56a-4226-4f62-a219-d3f89fe7afe32023-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d367e5-e846-54ba-e053-2991aa0a63d42023-01-12Exact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
DALEKTRO NSILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDEPEKANA Natruheilmittel GmbH2b39ce30-54ff-4586-bda1-d9410140b26e2023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
Vitrexyl plus IronFERROUS FUMARATE, FOLIC ACIDPureTek Corporationada43056-a3ce-e7de-e053-2a95a90aa0462023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Vitranol FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb81daf17-430b-6ba2-e053-2a95a90a768b2023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
VitrexateFOLIC ACIDPureTek Corporationb34fee43-bea9-45b7-e053-2a95a90aad4d2023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Vitrexate FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb3637def-a701-673a-e053-2995a90a02d52023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
VenexaFOLIC ACIDPureTek Corporationba130779-cdfd-086d-e053-2a95a90a25902023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
unii: SOI2LOH54Z
PSORIASISARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMZorex Internationalb5b8bb82-4d36-4faa-b023-e48066f4521c2023-01-09WarningsExact identifier
unii: 451W47IQ8X
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUMDeseret Biologicals, Inc.56555cb5-89e5-4a30-8ebe-ce2c01bdd4262023-01-03WarningsExact identifier
unii: 451W47IQ8X
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
KELANSILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOPPEKANA Naturheilmittel GmbH55786d99-ee1f-490f-9023-3e6c39da86b02022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
AILGENOAMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH4e24f727-4c83-46b6-9549-8f66bd1356472022-12-21WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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