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 60 of 403 · 8,045 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriplePaste Adult Care Rash TreatmentZINC OXIDEAdvantice Health, LLC2cf0575c-8d3d-1f16-e063-6294a90a629d2026-03-19WarningsExact identifier
unii: SOI2LOH54Z
multipurposeZINC OXIDE SKIN PROTECTANTAdvantice Health, LLC291563cc-7491-ce41-e063-6394a90ac6c12026-03-19WarningsExact identifier
unii: SOI2LOH54Z
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
unii: SOI2LOH54Z
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREENZINC OXIDECLIO COSMETICS Co., Ltd.c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e2026-03-18WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLEZINC OXIDECOSMAX USA4d318f51-1a43-44d5-e063-6394a90a49702026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVEZINC OXIDECOSMAX USA4d319110-e6a4-1ad3-e063-6394a90aa99c2026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORALZINC OXIDECOSMAX USA4d31b201-9d6a-730a-e063-6394a90a67002026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
unii: SOI2LOH54Z
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
application number: M020
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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