FDA.reportPublic FDA data

NDC 80554-003-01 - BIORLX LIP BALM GINSENG

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
80554-003
Requested NDC
80554-003-01
Package NDCs from labels
80554-003-01, 80554-003-02
Manufacturer
LOTUSA LLC. | FRENCH MALIHOME PERSONAL PRODUCTS LIMITED
Effective date
2020-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AVOBENZONE - LOTUSA LLC. | FRENCH MALIHOME PERSONAL PRODUCTS LIMITEDLOTUSA LLC. | FRENCH MALIHOME PERSONAL PRODUCTS LIMITED2020-09-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80554-003-022022-01-28C16284748780-1d6a99b39-c9a0-a426-e053-dadaa90af4c2af9b5a30-be5e-3918-e053-2995a90ae69c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80554-003-01BIORLX LIP BALM GINSENG3.5 g in 1 APPLICATORSTICK3.51
80554-003-02BIORLX LIP BALM GINSENG12 in 1 BOXSTICK121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80554-003BIORLX LIP BALM GINSENG (AVOBENZONE, MINERAL OIL, OCTINOXATE, PETROLATUM, ZINC OXIDE) STICK [LOTUSA LLC.]1Legacy NDC, 2 package rows20200919_af9b5a30-be5e-3918-e053-2995a90ae69c.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 314 of 371 · 7,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 4Y5P7MUD51
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 4Y5P7MUD51
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATESICOS ET CIE3b49a970-653b-4256-b2d3-4e065db638492024-06-24WarningsExact identifier
unii: 4Y5P7MUD51
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATEL'Oreal USA Products Inc.1b851e19-add0-437b-86e4-e88a10a1e7742024-06-24WarningsExact identifier
unii: 4Y5P7MUD51
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
unii: 4Y5P7MUD51
Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1b6bf419-554c-86a7-e063-6294a90a5a7e2024-06-21WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
OS-01 Body SPF 30ZINC OXIDEAllure Labs1b582f4e-553f-a511-e063-6294a90af3c02024-06-20WarningsExact identifier
unii: SOI2LOH54Z
Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50ZINC OXIDEThe Seaweed Bath Co.65c9c131-2545-4d88-aa9a-85197b654d742024-06-19WarningsExact identifier
unii: SOI2LOH54Z
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
unii: SOI2LOH54Z
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
unii: SOI2LOH54Z
EB-5 Super Hydrating Anti-Aging SPF-50OCTOCRYLENE, ZINC OXIDE, OCTISALATELIFE O, INC.b9521112-d119-4d48-8504-4e46b434f76f2024-06-17WarningsExact identifier
unii: SOI2LOH54Z
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
unii: SOI2LOH54Z
Burts Bees SPF 30 Untinted Lip Balm Beaches and CreamBURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAMAutumn Harp1ac89261-eeae-567c-e063-6294a90ad45f2024-06-13WarningsExact identifier
unii: SOI2LOH54Z
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: SOI2LOH54Z
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: 4T6H12BN9U
BOB KIDS SPF 30 Zinc onlyZINC OXIDESPF Ventures, LLC1aae0291-f16f-7840-e063-6394a90a34432024-06-12WarningsExact identifier
unii: SOI2LOH54Z
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
unii: SOI2LOH54Z
Glossier Invisible Shield SPF 50GLOSSIER INVISIBLE SHIELD SPF 50Autumn Harp1ab39eae-06e9-0e4c-e063-6394a90ad8aa2024-06-12WarningsExact identifier
unii: G63QQF2NOX
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
unii: 4T6H12BN9U
Thinksport SPF 50ZINC OXIDEthinkOperations,LLC2e83e382-8eb0-40f2-bdca-2db5e184661e2024-06-10WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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