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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
27c155dc-f194-6750-e063-6394a90a20b1	Available on FDA.report

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 68 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

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