Sunsolve MD Calm and Revitalize

Product NDC
84878-654
11-digit product format
848780654
Labeler code
84878
Product ID
84878-654_43923d19-4229-a579-e063-6294a90a87b9
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Sunsolve MD Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-08
Substance
ZINC OXIDE
Active strength
132 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sunsolve MD Calm and Revitalize
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84878-654-01Sunsolve MD Calm and Revitalize48 mL in 1 BOTTLE, PUMPLOTION484
84878-654-02Sunsolve MD Calm and Revitalize1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84878-654SUNSOLVE MD CALM AND REVITALIZE (ZINC OXIDE) LOTION [SUNSOLVE MD INC]2Current NDC, 2 package rows20250507_26f3f534-a305-3530-e063-6394a90a75e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84878-654-018487806540148 mL in 1 BOTTLE, PUMP48 mlHistorical
84878-654-02848780654021 BOTTLE, PUMP in 1 CARTON (84878-654-02) / 48 mL in 1 BOTTLE, PUMP (84878-654-01) 2024-11-08NoNoCurrent