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 |
|---|---|---|---|---|---|---|
| Dermaroller Anhydrous Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Owen Biosciences, Inc. | 04e82f1b-c893-4795-b7a9-0523e3ec7552 | 2025-01-10 | Warnings | 15FIX9V2JP |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy Inc | be0da1f0-06a1-11df-8a39-0800200c9a66 | 2025-01-10 | Warnings | ETJ7Z6XBU4 |
| Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | NEW SEASON DERMATOLOGY, PLLC | fecd72a3-c7e5-3dfa-e053-6394a90a7357 | 2025-01-09 | Warnings | 15FIX9V2JP |
| ECLIPSE SPF 50 PERFECTINT BEIGE | TITANIUM DIOXIDE, ZINC OXIDE | SCIENCE OF SKINCARE LLC | b69dda25-372f-15d9-e053-2995a90a8d3e | 2025-01-09 | Warnings | 15FIX9V2JP |
| Extreme Protect SPF 40 All Shades | ZINC OXIDE, TITANIUM DIOXIDE | Science of Skincare, LLC. | b69db78b-5f0e-8ca2-e053-2a95a90ac88c | 2025-01-09 | Warnings | 15FIX9V2JP |
| ECLIPSE SPF 50 ALL SHADES | TITANIUM DIOXIDE, ZINC OXIDE | SCIENCE OF SKINCARE LLC | 49df51e6-be9a-41be-b3e1-bfc062aaceaa | 2025-01-09 | Warnings | 15FIX9V2JP |
| AM-9 | SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLE | DNA Labs, Inc. | d7a00f0b-de4c-4bff-b8e0-86a82bed8bb9 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-8 | SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARY | DNA Labs, Inc. | c25cdcb5-9469-48bb-b216-0a9d8d644e12 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-23 | ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUS | DNA Labs, Inc. | b6365b49-06fb-4692-96f7-a5097b70bc91 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-16 | MGO ENERGIZER | DNA Labs, Inc. | 8292b900-86c1-47ea-81da-b587439c7664 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-21 | CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYE | DNA Labs, Inc. | 89967941-c4ee-4598-a66d-8a93d69a4d65 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-18 | OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLAND | DNA Labs, Inc. | 3565c5d5-dc68-4f3f-99ec-30f8952393e0 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-24 | METABOLIN | DNA Labs, Inc. | 559fca2b-1093-4bdf-be70-c453f87002c3 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| CoTZ Mineral Suns Stick - Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 44a6ff9b-8067-4f32-acb2-4ede54c79e6e | 2025-01-09 | Warnings | 15FIX9V2JP |
| NO-WEAK-NAILS | GRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDE | Miers Laboratories | 9158cd3f-4c27-40e9-bc07-fd560375c3a1 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| TiZO Tinted Lip Protection SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 | 2025-01-09 | Warnings | 15FIX9V2JP |
| CoTZ Face Prime and Protect SPF 40 (Tinted) | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 1088fbf6-5790-490d-b272-ec281b4b76fa | 2025-01-09 | Warnings | 15FIX9V2JP |
| CoTZ Face Prime and Protect SPF 40 (Non-Tinted) | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | f106f52b-2157-46c7-9f7c-50f43a649050 | 2025-01-09 | Warnings | 15FIX9V2JP |
| Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | ETHEREAL AESTHETICS LLC | 065d17cf-bea5-137f-e063-6394a90aeeb3 | 2025-01-08 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | SERRAO, E JOHN MD FACOG | fea61544-6684-ad34-e053-6294a90a48f3 | 2025-01-08 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.