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 125 of 279 · 5,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
unii: SOI2LOH54Z
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
unii: 4Y5P7MUD51
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
unii: 4Y5P7MUD51
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact identifier
unii: SOI2LOH54Z
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
unii: 4Y5P7MUD51
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
unii: SOI2LOH54Z
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
unii: 4Y5P7MUD51
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
unii: SOI2LOH54Z
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
unii: SOI2LOH54Z
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
unii: SOI2LOH54Z
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
unii: SOI2LOH54Z
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

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