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 64 of 379 · 7,580 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
unii: G63QQF2NOX
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
unii: G63QQF2NOX
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact identifier
unii: G63QQF2NOX
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
unii: G63QQF2NOX
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
unii: G63QQF2NOX
Multi-Strain Cold and Flu ReliefANAS BARBARIAE (35C, 50C, 100C, 200C), ARSENICUM ALB, BAPTISIA, BRYONIA, CAUSTICUM, CINCHONA, ECHINACEA PURP, EUCALYPTUS, EUPATORIUM PERF, GELSEMIUM, INFLUENZINUM, PHYTOLACCA, RHUS TOX, SARCOLACTICUM AC, SULPHUR, WYETHIA, ZINC ACET, ZINC MUR, AND ZINC OXYD.King Bio Inc.c7c5a103-3860-4792-b239-ddc7243a37252026-03-02WarningsExact identifier
unii: SOI2LOH54Z
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association6307627a-94e2-47ea-8519-68975716dd6e2026-02-27Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Sport Sunscreen SPF 30AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationa38e150e-2e50-4936-ae46-408f9cf82d152026-02-27Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association87811c86-19d2-4179-8d22-2aeb4680ff572026-02-27Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Sunscreen for Kids SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationd7215a32-00a9-4b70-8597-8ea91f546c1e2026-02-27Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Sport Sunscreen SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association9fccccd4-2d2e-4812-85b1-bbeb44ff04ea2026-02-27Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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