FDA.reportPublic FDA data

NDC 61354-030-03 - 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
61354-030-03
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 76 of 289 · 5,771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCIRetail Business Services, LLC9ab96aed-21d3-11b6-e053-2995a90a72252025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Equate Redness and Dry Eye Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWal-Mart Stores, Inc.ae228018-9238-2cbd-e053-2995a90a8d992025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
unii: SOI2LOH54Z
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
unii: SOI2LOH54Z
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: SOI2LOH54Z
VITACILINA Bebe Diaper RashALLANTOIN, ZINC OXIDECompania Internacional de Comercio, S.A.P.I de C.V.39726b59-bd85-4541-80e5-4f2919842dca2025-12-29WarningsExact identifier
unii: SOI2LOH54Z
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
unii: SOI2LOH54Z
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
unii: SOI2LOH54Z
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
unii: SOI2LOH54Z
Creamy Diaper RashZINC OXIDEDavion, Inc0fdfe7d3-e4cd-6bea-e063-6394a90a37f62025-12-29WarningsExact identifier
unii: SOI2LOH54Z
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: SOI2LOH54Z
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
unii: SOI2LOH54Z
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
unii: SOI2LOH54Z
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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