FDA.reportPublic FDA data

NDC 61354-070-01 - 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
61354-070
Requested NDC
61354-070-01
Package NDCs from labels
61354-070-01, 61354-070-05, 61354-070-02, 61354-070-06, 61354-070-03, 61354-070-07, 61354-070-04, 61354-070-08
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
61354-070-052025-01-30f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062025-01-30f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072025-01-30f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082025-01-30f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-052023-02-10f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062023-02-10f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072023-02-10f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082023-02-10f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-052023-01-30f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062023-01-30f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072023-01-30f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082023-01-30f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-070-01Cream40 mg in 1 TUBECREAM403
61354-070-02cream40 mg in 1 TUBECREAM403
61354-070-03cream40 mg in 1 TUBECREAM403
61354-070-04cream40 mg in 1 TUBECREAM403
61354-070-05Cream1 in 1 CARTONCREAM13
61354-070-06cream1 in 1 CARTONCREAM13
61354-070-07cream1 in 1 CARTONCREAM13
61354-070-08cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf4e4ca-8b3b-4298-e053-2995a90ad847.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf07182-f7d7-3790-e053-2a95a90a3798.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf2abeb-fe02-8422-e053-2a95a90ac374.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf3d3af-f30e-5491-e053-2995a90a22bb.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 28 of 281 · 5,616 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTELE COSMETICS INC5139cc37-62ac-514b-e063-6394a90a9ca32026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYLE COSMETICS INC5139d3c1-83d1-2ad9-e063-6394a90a69582026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXLE COSMETICS INC5138eb74-0223-6c1f-e063-6294a90a3bc62026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIELE COSMETICS INC513a0449-5494-5dfd-e063-6394a90a026e2026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOULE COSMETICS INC5139dab1-3c27-a59e-e063-6294a90a70962026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLELE COSMETICS INC513a0722-42ab-1051-e063-6294a90a8a1d2026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLELE COSMETICS INC513a12cf-0230-6a24-e063-6394a90afb952026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Zinc Oxide 20.00%SPF 50 MINERALCoconut Caliente Costa Rica LLC388f1e01-0feb-4c94-88a7-13c81368c6c82026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
unii: 25X51I8RD4
unii: SOI2LOH54Z
FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFFORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFHorizons Ventures LLC5127ac89-3dff-5966-e063-6394a90a11db2026-05-06WarningsExact identifier
unii: SOI2LOH54Z
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
unii: SOI2LOH54Z
unii: 4Y5P7MUD51
Vivaiodays Sunscreen with TurmericZINC OXIDE5SENCO INC DBA VIVAIODAYS5129e680-f485-9c66-e063-6394a90a0e7e2026-05-06WarningsExact identifier
unii: SOI2LOH54Z
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
unii: SOI2LOH54Z
THANKYOU FARMER Sun Project Soothing SunOCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATETHANK YOU FARMER CO., LTD300ab1bc-9c11-c2f0-e063-6394a90aa8532026-05-06WarningsExact identifier
unii: 4Y5P7MUD51
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50ZINC OXIDE, OCTINOXATEPrivate Label Skin Care9eb7f287-cb61-4f9d-968e-16b195dbbc9a2026-05-06WarningsExact identifier
unii: SOI2LOH54Z
unii: 4Y5P7MUD51
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
unii: 25X51I8RD4
unii: SOI2LOH54Z
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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