AM RESTORE

Product NDC
85364-208
11-digit product format
853640208
Labeler code
85364
Product ID
85364-208_4604bcf1-6b11-a71e-e063-6394a90acd8a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Minder Day Spa, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-10
Substance
ZINC OXIDE
Active strength
160 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
AM RESTORE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85364-208-15AM RESTORE1.5 g in 1 PACKETCREAM1.52
85364-208-50AM RESTORE50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85364-208AM RESTORE (ZINC OXIDE) CREAM [MINDER DAY SPA, INC.]1Current NDC, 1 package rows20250524_35c010ad-e25d-f197-e063-6294a90a0efb.zip
85364-208AM RESTORE (ZINC OXIDE) CREAM [MINDER DAY SPA, INC.]1Current NDC, 1 package rows20250524_35c03804-04e9-3d54-e063-6294a90a3407.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85364-208-15853640208151.5 g in 1 PACKET (85364-208-15) 1.5 g2023-07-10YesNoHistorical
85364-208-508536402085050 g in 1 BOTTLE, PUMP (85364-208-50) 50 g2020-05-13NoNoHistorical