FDA.reportPublic FDA data

Baby Butz

Product NDC
52358-0001
11-digit product format
523580001
Labeler code
52358
Product ID
52358-0001_54a236c7-4da3-f51d-e063-6394a90a56f0
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
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact 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
52358-0001-15235800010157 g in 1 JAR (52358-0001-1) 57 g2015-11-022027-10-01NoNoCurrent
52358-0001-252358000102113 g in 1 JAR (52358-0001-2) 113 g2015-11-022027-10-01NoNoCurrent
52358-0001-352358000103227 g in 1 JAR (52358-0001-3) 227 g2018-06-122027-10-01NoNoCurrent