FDA.reportPublic FDA data

NDC 61354-080-01 - 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
61354-080
Requested NDC
61354-080-01
Package NDCs from labels
61354-080-01, 61354-080-07, 61354-080-02, 61354-080-08, 61354-080-04, 61354-080-10, 61354-080-06, 61354-080-12
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
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
61354-080-072025-01-30f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082025-01-30f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102025-01-30f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122025-01-30f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac
61354-080-072023-02-10f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082023-02-10f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102023-02-10f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122023-02-10f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac
61354-080-072023-01-30f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082023-01-30f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102023-01-30f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122023-01-30f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-080-01Cream3 mg in 1 BOTTLECREAM32
61354-080-02Cream3 mg in 1 BOTTLECREAM32
61354-080-04Cream3 mg in 1 BOTTLECREAM32
61354-080-06Cream3 mg in 1 BOTTLECREAM32
61354-080-07Cream1 in 1 CARTONCREAM12
61354-080-08Cream1 in 1 CARTONCREAM12
61354-080-10Cream1 in 1 CARTONCREAM12
61354-080-12Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bbeffa0a-2bc6-fea4-e053-2a95a90ac511.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc07accc-5604-6c68-e053-2995a90a0a7e.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc081c9a-7cc8-8b4e-e053-2995a90a8f92.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc0734fd-6c6d-3c9c-e053-2995a90aa615.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 108 of 131 · 2,608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
unii: 15FIX9V2JP
DV HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.74bda12d-5e3d-4f52-9e3f-98012c92fc912024-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
unii: 15FIX9V2JP
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 15FIX9V2JP
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc6d3c5fc5-c818-46c4-8db3-cffcdcd56e062023-12-31WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide MineralTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incbcf5e724-b40a-49dd-8a09-57cefd7f65ad2023-12-31WarningsExact identifier
unii: 15FIX9V2JP
CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEL'Oreal USA Products Inc27d82e37-67ac-4cd3-83c0-fb8388d3a0dd2023-12-31WarningsExact identifier
unii: 15FIX9V2JP
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8e94e203-d3cf-45a1-88f9-6999f0aab22b2023-12-31WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3d9ed59f-f280-4cc2-a0f1-4180deb5b7922023-12-30WarningsExact identifier
unii: 15FIX9V2JP
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
unii: 15FIX9V2JP
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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