FDA.reportPublic FDA data

Baby Butz

Product NDC
52358-0001
Requested package NDC
52358-0001-2
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
Marketing end
2027-10-01
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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1432509Internal RxNorm lookup
1432514Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6be6b62-13a4-410d-b8ac-457b58fd23daAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

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
52358-0001-252358000102113 g in 1 JAR (52358-0001-2) 113 g2015-11-020000-00-00NoNoCurrent