Softlips Pearl

Product NDC
10742-8573
11-digit product format
107428573
Labeler code
10742
Product ID
10742-8573_2979d20c-f978-246c-e063-6294a90a2df5
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, octisalate
Dosage form
STICK
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-02-01
Substance
OCTINOXATE; OCTISALATE
Active strength
75; 50 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Softlips Pearl
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8573-12023-02-07C16284748780-1f386c64a-2125-0266-e053-dadaa90a7c1aDrug Facts - Softlips Pearl
10742-8573-12023-01-30C16284748780-1f386c64a-2125-0266-e053-dadaa90a7c1aDrug Facts - Softlips Pearl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8573-1Softlips Pearl1 in 1 BLISTER PACKSTICK13
10742-8573-1Softlips Pearl2 g in 1 TUBESTICK23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8573SOFTLIPS PEARL (OCTINOXATE, OCTISALATE) STICK [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_43e175b4-7a48-431e-bf27-9ce7dee53f5e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8573-1107428573011 TUBE in 1 BLISTER PACK (10742-8573-1) / 2 g in 1 TUBE1 tube2010-02-010000-00-00NoNoCurrent