Replenix Lip Therapy

Product NDC
51326-102
11-digit product format
513260102
Labeler code
51326
Product ID
51326-102_cda6e73e-8e21-48d6-bd98-282e4a06ff32
Type
HUMAN OTC DRUG
Nonproprietary name
homosalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Topiderm, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-02
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength
30; 150; 75; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Replenix Lip Therapy
Brand name suffix
homosalate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51326-102-042025-01-30C16284748780-12cef2736-80c4-d83d-e063-dadaa90ab31fREPLENIX ® Lip Therapy homosalate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-102-04Replenix Lip Therapyhomosalate4 g in 1 BOTTLELIPSTICK47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-102REPLENIX LIP THERAPY HOMOSALATE (HOMOSALATE) LIPSTICK [TOPIDERM, INC.]5Current NDC, 1 package rows20230209_b60dc004-d713-47bc-a6e9-ea4783aa7019.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51326-102-04513260102044 g in 1 BOTTLE (51326-102-04) 4 g2022-01-02NoNoHistorical