FDA.reportPublic FDA data

NDC 80554-001-01 - BIORLX LIP BALM HEMP

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
80554-001
Requested NDC
80554-001-01
Package NDCs from labels
80554-001-01, 80554-001-02
Manufacturer
LOTUSA LLC | FRENCH MALIHOME PERSONAL PRODUCTS LIMITED
Effective date
2020-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BIORLX LIP BALM HEMP - LOTUSA LLC | FRENCH MALIHOME PERSONAL PRODUCTS LIMITEDLOTUSA LLC | FRENCH MALIHOME PERSONAL PRODUCTS LIMITED2020-09-16HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80554-001-022022-01-28C16284748780-1d6a99b39-7bba-a426-e053-dadaa90af4c2af78a54c-ff15-d9e1-e053-2a95a90aec14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80554-001-01BIORLX LIP BALM HEMP3.5 g in 1 APPLICATORSTICK3.51
80554-001-02BIORLX LIP BALM HEMP12 in 1 BOXSTICK121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80554-001BIORLX LIP BALM HEMP (AVOBENZONE, MINERAL OIL, OCTINOXATE, PETROLATUM,ZINC OXIDE) STICK [LOTUSA LLC]1Legacy NDC, 2 package rows20200919_af78a54c-ff15-d9e1-e053-2a95a90aec14.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 66 of 379 · 7,580 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panama Jack SPF 45 Flavorless Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack1b15c00b-0e78-4dbe-877c-de3941ffe76e2026-02-26WarningsExact identifier
unii: 4T6H12BN9U
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
unii: G63QQF2NOX
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
unii: SOI2LOH54Z
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
unii: SOI2LOH54Z
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: 4T6H12BN9U
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
unii: SOI2LOH54Z
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
unii: G63QQF2NOX
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
unii: G63QQF2NOX
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
unii: SOI2LOH54Z
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 4Y5P7MUD51
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
unii: SOI2LOH54Z
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
unii: SOI2LOH54Z
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 4Y5P7MUD51
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
unii: 4T6H12BN9U
unii: G63QQF2NOX
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
unii: 4T6H12BN9U
unii: G63QQF2NOX
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
unii: 4T6H12BN9U
unii: G63QQF2NOX
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
unii: 4T6H12BN9U
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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