BIORLX LIP BALM HEMP

Product NDC
80554-001
11-digit product format
805540001
Labeler code
80554
Product ID
80554-001_af786d13-df27-6075-e053-2995a90a5115
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Mineral Oil, Octinoxate, Petrolatum,Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
LOTUSA LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ZINC OXIDE; OCTINOXATE; PETROLATUM; MINERAL OIL; AVOBENZONE
Active strength
6 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80554-001-01805540001013.5 g in 1 APPLICATOR3.5 gHistorical
80554-001-028055400010212 APPLICATOR in 1 BOX (80554-001-02) > 3.5 g in 1 APPLICATOR (80554-001-01) 12 applicator2020-09-010000-00-00NoNoCurrent