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 36 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gerigentle-Vitamins A and D PETROLATUM Geri-Gentle Corporation c36c74f7-975b-4e4c-99e3-e6921d782c71 2025-10-17 Warnings Exact identifier application number: M016 Seacall Dexamethasone Ointment. DEXAMETHASONE OINTMENT Guangdong Quadrant Ecological Technology Co., Ltd. 201adf67-773c-34a2-e063-6394a90ac525 2025-10-15 Warnings Exact identifier application number: M016 Medline ZINC OXIDE Medline Industries, LP dae45414-7401-9536-e053-2a95a90a0a86 2025-10-15 Warnings Exact identifier application number: M016 Curology Barrier Balm SKIN BARRIER BALM Curology 04b2ba38-0f81-be51-e063-6294a90af821 2025-10-15 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Medline Industries, LP 34f3581f-39ba-4f28-9237-52f3820ab4c0 2025-10-09 Warnings Exact identifier application number: M016 Facial Fortress PYRITHIONE ZINC Pediatric Solutions, LLC cdd3c52e-4c32-46c1-bdb3-957b164190bb 2025-10-08 Warnings Exact identifier application number: M016 Happy Cappy PYRITHIONE ZINC Pediatric Solutions, LLC 3d3828d8-ee15-4aff-99d1-a121f0102a00 2025-10-08 Warnings Exact identifier application number: M016 Purforma Advanced Hand Sanitizer 70% Alcohol HAND SANITIZER 70% ALCOHOL Spartan Chemical Company, Inc. 06bd825d-914f-5ca7-e063-6394a90aec49 2025-10-06 Warnings Exact identifier application number: M016 Scar Reducer Intensive Herbal and Nutrient ALLANTOIN Quantum, Inc 5197f1fa-aae5-406c-97d9-635b8c1a88a8 2025-10-06 Warnings Exact identifier application number: M016 PURE SOL SPF 30 LIP BALM CACOA BUTTER ZINC OXIDE Brand 2022b LLC 40537561-d334-5859-e063-6394a90a92a7 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss original ZINC OXIDE Brand 2022b LLC 4056e49a-2976-38f9-e063-6394a90a786d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Nudie rose ZINC OXIDE Brand 2022b LLC 4057b0e2-1c31-abae-e063-6294a90a053d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Pink coral ZINC OXIDE Brand 2022b LLC 405865dd-7d0e-048d-e063-6394a90ab105 2025-10-04 Warnings Exact identifier application number: M016 HealthWise Medicated Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 164f4cd8-975a-40d5-e063-6394a90ae7d5 2025-10-02 Warnings Exact identifier application number: M016 THE ZOEUN SKIN TOTAL CARE COLLOIDAL OATMEAL, STURGEON EXTRACT Sturgeonbio Co.,Ltd. 42712685-64d4-0170-e063-6394a90a75d7 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Total Cleanser COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 4275eecd-67bb-fb1c-e063-6294a90aa09a 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Mist Toner COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42766f41-74bc-d19d-e063-6294a90aba53 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Y-Zone Feminine Moisturizer COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42773426-f39f-bebe-e063-6394a90a73d9 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Eye Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42792a80-555b-e86c-e063-6294a90a2f30 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Night Mask COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42843691-8761-3f32-e063-6394a90a59bc 2025-10-01 Warnings Exact identifier application number: M016
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