FDA.reportPublic FDA data

NDC 61354-030-01 - 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
61354-030
Requested NDC
61354-030-01
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 234 of 282 · 5,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VAXR HCTHUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODEDeseret Biologicals, Inc.fdf8d21a-2ae1-4842-abf3-7378419959392024-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBEL STAR S Aea3a0e07-a277-48c8-e053-2a95a90a172f2024-04-02WarningsExact identifier
unii: SOI2LOH54Z
Good Molecules Sheer Mineral Sunscreen SPF 30ZINC OXIDEGood Molecules, LLCe9596344-a7ab-f582-e053-2a95a90a55252024-04-02WarningsExact identifier
unii: SOI2LOH54Z
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Rejuvenating Priming Moisturizer BS Sunscreen SPF30ZINC OXIDEAllure Labs14cff1a3-89b9-f4da-e063-6394a90a1a412024-03-29WarningsExact identifier
unii: SOI2LOH54Z
Lemongrass Spa Products SPF 45 Tinted Mineral SunscreenZINC OXIDELemongrass Spa Products, LLC14bcbaf9-76a5-f8ba-e063-6294a90a91f62024-03-28WarningsExact identifier
unii: SOI2LOH54Z
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: SOI2LOH54Z
NAELI TINT Tinted Mineral Moisturizer SPF 50ZINC OXIDEALLI LLC25a88843-078b-4589-b8b7-ea439ba6a15b2024-03-27WarningsExact identifier
unii: SOI2LOH54Z
Rio Radiance SPF 50 BodyLotionZINC OXIDESOL DE JANEIRO USA, INC.14a85a88-c9a2-94ea-e063-6394a90a4e142024-03-27WarningsExact identifier
unii: SOI2LOH54Z
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: SOI2LOH54Z
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: SOI2LOH54Z
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.95406534-526e-4bca-b73d-1030623549a32024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
V-Fem CareAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.14800c19-e5c6-924b-e063-6394a90a15e52024-03-25WarningsExact identifier
unii: 451W47IQ8X
Eminence Daily Defense Tinted SPFZINC OXIDEEminence Organic Skin Care14854bad-317e-154d-e063-6294a90a884f2024-03-25WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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