NDC 61354-080-01 - 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
- 61354-080
- Requested NDC
- 61354-080-01
- Package NDCs from labels
- 61354-080-01, 61354-080-07, 61354-080-02, 61354-080-08, 61354-080-04, 61354-080-10, 61354-080-06, 61354-080-12
- 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 | Type |
|---|---|---|---|
| Cream - Oxygen Development LLC | Oxygen Development LLC | 2023-02-10 | HUMAN OTC DRUG LABEL |
| Cream - Oxygen Development LLC | Oxygen Development LLC | 2023-02-10 | HUMAN OTC DRUG LABEL |
| Cream - Oxygen Development LLC | Oxygen Development LLC | 2023-02-10 | HUMAN OTC DRUG LABEL |
| Cream - Oxygen Development LLC | Oxygen Development LLC | 2023-02-10 | HUMAN OTC DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-080-01 | Cream | 3 mg in 1 BOTTLE | CREAM | 3 | 2 | |
| 61354-080-02 | Cream | 3 mg in 1 BOTTLE | CREAM | 3 | 2 | |
| 61354-080-04 | Cream | 3 mg in 1 BOTTLE | CREAM | 3 | 2 | |
| 61354-080-06 | Cream | 3 mg in 1 BOTTLE | CREAM | 3 | 2 | |
| 61354-080-07 | Cream | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 61354-080-08 | Cream | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 61354-080-10 | Cream | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 61354-080-12 | Cream | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61354-080 | CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbeffa0a-2bc6-fea4-e053-2a95a90ac511.zip |
| 61354-080 | CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc07accc-5604-6c68-e053-2995a90a0a7e.zip |
| 61354-080 | CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc081c9a-7cc8-8b4e-e053-2995a90a8f92.zip |
| 61354-080 | CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc0734fd-6c6d-3c9c-e053-2995a90aa615.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Reflecting Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Helande, LLC | 3750f04b-7f9f-8793-e063-6294a90a9143 | 2025-06-11 | Warnings | 15FIX9V2JP |
| SHISEIDO ULTIMATE SUN PROTECTION S | TITANIUM DIOXIDE AND ZINC OXIDE | Shiseido Americas Corporation | b2fae1ba-67fe-48ef-b31f-62db34349961 | 2025-06-09 | Warnings | 15FIX9V2JP |
| HAIR STIM | PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR | The Wellness Center for Research and Education, Inc. | 8ecc05ff-ed5a-4157-9100-1c7912686f07 | 2025-06-06 | Warnings | ETJ7Z6XBU4 |
| SLIM | LYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTIN | The Wellness Center for Research and Education | 5067953f-351e-4bb0-b165-8dc62077cdea | 2025-06-06 | Warnings | ETJ7Z6XBU4 |
| BioTox Dental Foci Repair | ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA | The Wellness Center For Research and Education | 767f8dd2-759f-4662-9b5c-b8832309363d | 2025-06-06 | Warnings | ETJ7Z6XBU4 |
| Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields Beauty, LLC | afa2d42e-b54d-4843-b313-0c44fe5c5d52 | 2025-06-06 | Warnings | 15FIX9V2JP |
| Silicea 6X | SILICEA 6X | True Botanica, LLC | 2cee8f0b-6d28-75e4-e063-6294a90a2e15 | 2025-06-05 | Warnings | ETJ7Z6XBU4 |
| Body Glove Sunscreen SPF 30 | ZINC OXIDE, TITANIUM DIOXIDE | SCUBASCREEN LLC | 1d7a960c-4387-44dc-8d4e-881e21a8ae2e | 2025-06-05 | Warnings | 15FIX9V2JP |
| Non Tinted Mineral Sunscreen Stick | TITANIUM DIOXIDE, ZINC OXIDE | BABYFACE LLC | 36d7c8b3-554f-78d9-e063-6394a90a80f3 | 2025-06-05 | 15FIX9V2JP | |
| Tinted Mineral Sunscreen Stick | TITANIUM DIOXIDE, ZINC OXIDE | BABYFACE LLC | 36d80422-943f-3aba-e063-6294a90afb59 | 2025-06-05 | 15FIX9V2JP | |
| Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | f8e178d6-058c-462a-8e59-6721f28ad040 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | adcd6881-fa25-4312-95e5-5b47102aa6b9 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Mineral Moisture Defense SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | 05ad73f3-a4e8-4f78-8212-3e8e3bda988c | 2025-06-05 | Warnings | 15FIX9V2JP |
| Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | 6ce602bb-c1f4-43c1-ae61-0f05d7952db3 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | b8f08778-7e5e-4341-9a24-1ce57c6525c7 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Nemah, Inc. | 36da2d94-fa90-b145-e063-6394a90a5854 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | 4c7f0257-fa12-40d6-9516-824b0e3a182c | 2025-06-05 | Warnings | 15FIX9V2JP |
| Mineral KidCreme SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | 9ec56c68-6fea-444b-aeed-0b5d60c42e75 | 2025-06-05 | Warnings | 15FIX9V2JP |
| Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Kenvue Brands LLC | fbf8be03-93e2-4d7e-e053-6294a90a4fd5 | 2025-06-04 | Warnings | 15FIX9V2JP |
| Age Defense for Eyes 5 in 1 | ZINC OXIDE AND TITANIUM DIOXIDE | Topiderm, Inc. | 48d5343a-1068-4c64-a275-c180026d6947 | 2025-06-03 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.