Mentholatum Medicated Lip Balm

Product NDC
10742-8865
11-digit product format
107428865
Labeler code
10742
Product ID
10742-8865_2979ebf9-e75f-6f98-e063-6394a90a49f4
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-01
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE
Active strength
10; 75; 50 mg/g; mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mentholatum Medicated Lip Balm
Brand name suffix
Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE10 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 4Y5P7MUD51, 4X49Y0596W

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8865-1Mentholatum Medicated Lip BalmOriginal4.2 g in 1 TUBEOINTMENT4.24
10742-8865-1Mentholatum Medicated Lip BalmOriginal1 in 1 BLISTER PACKOINTMENT14
10742-8865-3Mentholatum Medicated Lip BalmOriginal3 in 1 BLISTER PACKOINTMENT34
10742-8865-3Mentholatum Medicated Lip BalmOriginal4.2 g in 1 TUBEOINTMENT4.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8865MENTHOLATUM MEDICATED LIP BALM ORIGINAL (DIMETHICONE, OCTINOXATE, OCTISALATE) OINTMENT [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 4 package rows20241219_f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8865-1107428865011 TUBE in 1 BLISTER PACK (10742-8865-1) / 4.2 g in 1 TUBE1 tube2016-08-010000-00-00NoNoCurrent
10742-8865-3107428865033 TUBE in 1 BLISTER PACK (10742-8865-3) / 4.2 g in 1 TUBE3 tube2018-10-010000-00-00NoNoCurrent