Softlips

Product NDC
10742-7010
11-digit product format
107427010
Labeler code
10742
Product ID
10742-7010_2978bad6-a80c-3a8f-e063-6394a90a9c54
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate, oxybenzone
Dosage form
STICK
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-09
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
Peppermint Mocha, Apple Chai Cider, Orange Cranberry
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
10742-7010-12023-02-07C16284748780-1f386c649-ceac-0266-e053-dadaa90a7c1aDrug Facts
10742-7010-12023-01-30C16284748780-1f386c649-ceac-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-7010-1SoftlipsPeppermint Mocha, Apple Chai Cider, Orange Cranberry2 g in 1 TUBESTICK23
10742-7010-1SoftlipsPeppermint Mocha, Apple Chai Cider, Orange Cranberry3 in 1 BLISTER PACKSTICK33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-7010SOFTLIPS PEPPERMINT MOCHA, APPLE CHAI CIDER, ORANGE CRANBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_0338c078-695d-4d4e-9e90-5a8a98d49524.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-7010-1107427010013 TUBE in 1 BLISTER PACK (10742-7010-1) / 2 g in 1 TUBE3 tube2020-11-090000-00-00NoNoCurrent