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 322 of 371 · 7,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance FreeHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLC658b1b20-6540-4f3a-ac9a-170bc8fcba112024-03-06WarningsExact identifier
unii: SOI2LOH54Z
Daily Facial Moisturizer SPF 15 EQBAVOBENZONE 3% OCTOCRYLENE 10%Walmarta0c452a9-3e99-41b8-b9b2-c1b57b66f1832024-03-06WarningsExact identifier
unii: G63QQF2NOX
Target Up and Up Sport SPF 50AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb81b2e7e-6d7f-fa1d-e053-2995a90a7d152024-03-06WarningsExact identifier
unii: G63QQF2NOX
Target Up and Up Reef Conscious Formula SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONb5fd43ee-9fa1-13c1-e053-2995a90a364a2024-03-06WarningsExact identifier
unii: G63QQF2NOX
Vacation SPF 30 Baby OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f6030311-5287-3aa3-e053-2995a90a1b872024-03-06WarningsExact identifier
unii: G63QQF2NOX
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
unii: SOI2LOH54Z
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
unii: 4T6H12BN9U
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
unii: SOI2LOH54Z
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
unii: SOI2LOH54Z
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
unii: SOI2LOH54Z
Dermachange SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPrivate Label Beauty and Wellness12f00cee-dd9b-19b1-e063-6294a90adccb2024-03-05WarningsExact identifier
unii: G63QQF2NOX
Brush On Block Quick Stick SPF 40 Mineral StickZINC OXIDESPF Ventures LLC12d10ec9-847a-7483-e063-6294a90a42a72024-03-04WarningsExact identifier
unii: SOI2LOH54Z
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc OxideZINC OXIDELucin Organics, LLCd717dda8-60bb-40a0-86f9-6d724d695d162024-03-04WarningsExact identifier
unii: SOI2LOH54Z
Brush On Block Bounce Butter SPF 30 Moisturizing MousseZINC OXIDESPF Ventures LLC12956754-b4e5-0203-e063-6294a90a2b962024-03-01WarningsExact identifier
unii: SOI2LOH54Z
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
unii: 4T6H12BN9U
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
unii: SOI2LOH54Z
Derma E Sun Protection Mineral SPF 30ZINC OXIDEderma ebb8e3df2-23e8-4ad0-a662-ff02d156e7b12024-02-26WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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