FDA.reportPublic FDA data

NDC 61354-115-01 - 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
61354-115
Requested NDC
61354-115-01
Package NDCs from labels
61354-115-01, 61354-115-02
Manufacturer
Oxygen Development LLC
Effective date
2023-10-26
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 LLC2023-10-26HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-115-01Cream100 mg in 1 TUBECREAM1001
61354-115-02Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-115CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]1Current NDC, 2 package rows20231030_08a1e862-b55a-fb84-e063-6294a90a016a.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 53 of 403 · 8,045 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arizona Sun Products Lipkist Lip Balm SPF 15LIP BALMArizona Sun Products11fbcb81-2735-53c8-e063-6394a90ab0fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd8776-99f8-e5a4-e063-6394a90a20332026-04-09WarningsExact identifier
application number: M020
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
application number: M020
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
application number: M020
Sunright 50AVOBENZONE, HOMOSALATE, AND OCTINOXATENSE Products, Inc.b1b76481-da23-427f-9b34-b987019fa5322026-04-09WarningsExact identifier
application number: M020
ThinkBaby SPF 30ZINC OXIDEthinkOperations,LLC06862b00-c937-41af-ab5d-cea34160d0352026-04-09WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.4a376e93-85e8-40a5-8641-d3e3d11fdeea2026-04-08WarningsExact identifier
application number: M020
AGE20S UV MINERAL PRIMING SUNSCREENZINC OXIDEAekyung Industrial Co., Ltd.43c1f70b-0664-40be-e063-6394a90a2b482026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
AGE20S SUNSCREEN DUOZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAekyung Industrial Co., Ltd.4eef11cd-85a1-0e44-e063-6394a90a5d442026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef669b9-df00-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef6a60a-6634-e79b-e063-6394a90a3daa2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Sunright Lip BalmOCTINOXATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.dfdb2d0a-c646-4c44-b648-e2fdd604cdc92026-04-08WarningsExact identifier
application number: M020

Reported adverse events (FAERS/openFDA)#

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