Softlips

Product NDC
10742-7009
11-digit product format
107427009
Labeler code
10742
Product ID
10742-7009_2978aff0-b45f-d773-e063-6294a90a4fc1
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate, oxybenzone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-03
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
20; 75; 30; 30 mg/g; 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
Softlips
Brand name suffix
Vanilla, Watermelon, Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/g
OCTINOXATE75 mg/g
OCTISALATE30 mg/g
OXYBENZONE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-7009-12023-02-07C16284748780-1f386c64a-3595-0266-e053-dadaa90a7c1aDrug Facts
10742-7009-12023-01-30C16284748780-1f386c64a-3595-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-7009-1SoftlipsVanilla, Watermelon, Cherry2 g in 1 TUBEOINTMENT23
10742-7009-1SoftlipsVanilla, Watermelon, Cherry3 in 1 BLISTER PACKOINTMENT33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-7009SOFTLIPS VANILLA, WATERMELON, CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_2235d029-157e-4a30-be90-605e6bc143fd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-7009-1107427009013 TUBE in 1 BLISTER PACK (10742-7009-1) / 2 g in 1 TUBE3 tube2020-04-030000-00-00NoNoCurrent