Home NDC 61387-255 Truelipids TrueLips Lip Balm
Product NDC 61387-255
11-digit product format 613870255
Labeler code 61387
Product ID 61387-255_460132de-7181-aab5-e063-6394a90ad1ea
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum
Dosage form SOLUTION
Route TOPICAL
Labeler Claridei Laboratories, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-29
Substance PETROLATUM
Active strength 50 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Truelipids TrueLips Lip Balm
Brand name suffix CL MD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 50 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61387-255-01 Truelipids TrueLips Lip BalmCL MD 15 g in 1 TUBE SOLUTION 15 3 61387-255-02 Truelipids TrueLips Lip BalmCL MD 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61387-255 TRUELIPIDS TRUELIPS LIP BALM CL MD (WHITE PETROLATUM) SOLUTION [CLARIDEI LABORATORIES, INC.] 1 Current NDC, 2 package rows 20241204_27c155dc-f194-6750-e063-6394a90a20b1.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 45 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61387-255-01 61387025501 15 g in 1 TUBE 15 g Historical 61387-255-02 61387025502 1 TUBE in 1 CARTON (61387-255-02) / 15 g in 1 TUBE (61387-255-01) 1 tube 2024-11-29 No No Current