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 204 of 378 · 7,545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip Balm - Variety Pack (Target) - Banana (4)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cbcae23-9b38-edaa-e063-6294a90a2e8f2025-08-19WarningsExact identifier
unii: G63QQF2NOX
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30ZINC OXIDESun Bum, LLC3cbeb4ce-6d7c-387c-e063-6394a90af7902025-08-19WarningsExact identifier
unii: SOI2LOH54Z
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
unii: G63QQF2NOX
Sun Bum 30 Mineral Sunscreen Lip BalmZINC OXIDESun Bum, LLC3cbfba65-5702-50b5-e063-6394a90a409d2025-08-19WarningsExact identifier
unii: SOI2LOH54Z
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50ZINC OXIDESun Bum, LLC324e8ddb-89d2-08ca-e063-6294a90ab6c12025-08-19WarningsExact identifier
unii: SOI2LOH54Z
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: SOI2LOH54Z
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Sun Bum 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b02811d-dc66-fc6f-e063-6294a90aefc82025-08-18WarningsExact identifier
unii: G63QQF2NOX
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b058b74-27d0-8f8a-e063-6294a90aa02c2025-08-18WarningsExact identifier
unii: G63QQF2NOX
PLAY Mineral Stick SPF 50 with Olive Fruit ExtractZINC OXIDESupergoop LLC3ca7e1ed-7cc7-76b0-e063-6394a90ade932025-08-18WarningsExact identifier
unii: SOI2LOH54Z
Sun Bum Mineral 30 Sunscreen 6 OZZINC OXIDESun Bum, LLC3b91a7e3-ce52-6aa0-e063-6394a90a15e72025-08-18WarningsExact identifier
unii: SOI2LOH54Z
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
unii: SOI2LOH54Z
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b154009-9c6f-eadf-e063-6394a90ae4242025-08-18WarningsExact identifier
unii: G63QQF2NOX
Sun Bum Kids 50 Clear Sunscreen 6 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b162348-0222-490e-e063-6394a90ad4942025-08-18WarningsExact identifier
unii: G63QQF2NOX
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b169860-66bc-dd02-e063-6294a90a79742025-08-18WarningsExact identifier
unii: G63QQF2NOX
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
unii: SOI2LOH54Z
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
unii: SOI2LOH54Z
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3b1a0596-b852-16be-e063-6394a90a34982025-08-18WarningsExact identifier
unii: SOI2LOH54Z
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZOCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3b29dbfc-0b92-eb0f-e063-6294a90a16e12025-08-18WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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