Replenix Sheer

Product NDC
51326-858
11-digit product format
513260858
Labeler code
51326
Product ID
51326-858_1abf4f5e-ecc6-41c4-9bfb-617ad5a786fd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Topiderm, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-23
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
23; 165 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
Replenix Sheer
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE23 mg/g
ZINC OXIDE165 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-858-01Replenix SheerSPF 5060 g in 1 BOTTLE, PLASTICCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-858REPLENIX SHEER SPF 50 (ZINC OXIDE TITANIUM DIOXIDE) CREAM [TOPIDERM, INC.]1Current NDC, 1 package rows20240730_37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51326-858-015132608580160 g in 1 BOTTLE, PLASTIC (51326-858-01) 60 g2021-07-23NoNoHistorical