FDA.reportPublic FDA data

Baby Butz

Product NDC
52358-0001
11-digit product format
523580001
Labeler code
52358
Product ID
52358-0001_05e353aa-b693-bfbf-e063-6294a90a44fd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Olen Skin Care Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-15
Substance
ZINC OXIDE
Active strength
17.1 g/57g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baby Butz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.1 g/57g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui1432509, 1432514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52358-0001-1Baby Butz57 g in 1 JARCREAM576
52358-0001-2Baby Butz113 g in 1 JARCREAM1136
52358-0001-3Baby Butz227 g in 1 JARCREAM2276

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBABY BUTZ (ZINC OXIDE) CREAM [OLEN COSMETICS CORPORATION]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBABY BUTZ (ZINC OXIDE) CREAM [OLEN COSMETICS CORPORATION]2
LANOLININACTIVE INGREDIENT7EV65EAW6HBABY BUTZ (ZINC OXIDE) CREAM [OLEN COSMETICS CORPORATION]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBABY BUTZ (ZINC OXIDE) CREAM [OLEN COSMETICS CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBABY BUTZ (ZINC OXIDE) CREAM [OLEN COSMETICS CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52358-0001BABY BUTZ (ZINC OXIDE) CREAM [OLEN SKIN CARE CORPORATION]6Current NDC, Legacy NDC, 3 package rows20231011_e6be6b62-13a4-410d-b8ac-457b58fd23da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1432514Baby Butz Diaper Rash 30 % Topical CreamPSNe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432509zinc oxide 30 % Topical CreamPSNe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432514zinc oxide 300 MG/ML Topical Cream [Baby Butz Diaper Rash]SBDe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432509zinc oxide 300 MG/ML Topical CreamSCDe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432514Baby Butz Diaper Rash 30 % Topical CreamSYe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432514Baby Butz Diaper Rash 300 MG/ML Topical CreamSYe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432509ZNO 300 MG/ML Topical CreamSYe6be6b62-13a4-410d-b8ac-457b58fd23da6
1432514ZNO 300 MG/ML Topical Cream [Baby Butz Diaper Rash]SYe6be6b62-13a4-410d-b8ac-457b58fd23da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52358-0001-15235800010157 g in 1 JAR (52358-0001-1) 57 g2015-11-020000-00-00NoNoCurrent
52358-0001-252358000102113 g in 1 JAR (52358-0001-2) 113 g2015-11-020000-00-00NoNoCurrent
52358-0001-352358000103227 g in 1 JAR (52358-0001-3) 227 g2018-06-120000-00-00NoNoCurrent