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 301 of 371 · 7,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6044f0f-eb86-684d-e053-2995a90a09212024-10-14WarningsExact identifier
unii: SOI2LOH54Z
SIGNATURE CARE SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a62848fb-7016-3457-e053-2a95a90aa0f12024-10-14WarningsExact identifier
unii: G63QQF2NOX
Safeway Signature Care Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENESafeway, Inc.c6a0ae3e-d68a-b838-e053-2a95a90a77f72024-10-14WarningsExact identifier
unii: G63QQF2NOX
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a628ff71-463d-4d39-e053-2995a90a7a422024-10-14WarningsExact identifier
unii: G63QQF2NOX
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONESafeway, Inc.c5106c63-af51-c169-e053-2a95a90afef22024-10-14WarningsExact identifier
unii: G63QQF2NOX
Safeway Signature Care Dry Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESafeway, Inc.c6267a29-46a5-5f38-e053-2a95a90a01172024-10-14WarningsExact identifier
unii: G63QQF2NOX
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30ZINC OXIDESafeway, Inc.dbeff8e8-250d-8274-e053-2995a90a984e2024-10-14WarningsExact identifier
unii: SOI2LOH54Z
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: 4T6H12BN9U
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
unii: 4T6H12BN9U
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, ZINC OXIDERare Beauty, LLC2460281d-d433-0216-e063-6394a90a9d482024-10-13WarningsExact identifier
unii: SOI2LOH54Z
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
unii: 4T6H12BN9U
Walgreens 50 Coconut Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436987c-2afe-06b5-e063-6394a90aceba2024-10-11WarningsExact identifier
unii: G63QQF2NOX
Walgreens 50 Banana Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436bd19-2299-6e89-e063-6394a90acd992024-10-11WarningsExact identifier
unii: G63QQF2NOX
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
unii: SOI2LOH54Z
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf07238df-4970-7759-e053-2a95a90a39f92024-10-11WarningsExact identifier
unii: G63QQF2NOX
Walgreens SPF 70 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWALGREEN COMPANYe7165b39-54f9-4af6-e053-2a95a90af6642024-10-11WarningsExact identifier
unii: G63QQF2NOX
WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf14bb3b4-1dce-06b9-e053-2995a90a8bc82024-10-11WarningsExact identifier
unii: G63QQF2NOX
Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf12c9767-7cb7-12c8-e053-2995a90a17be2024-10-11WarningsExact identifier
unii: G63QQF2NOX
Sulwhasoo UV Daily CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAMAmorepacific Corporatione00451d5-8433-c4e8-e053-2a95a90a62442024-10-11WarningsExact identifier
unii: G63QQF2NOX
Walgreens SPF 50 Sport Continuous SunscreenAVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf13ec3da-2dc2-04f7-e053-2995a90a198d2024-10-11WarningsExact identifier
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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