FDA.reportPublic FDA data

Z-Bum

Product NDC
58809-375
11-digit product format
588090375
Labeler code
58809
Product ID
58809-375_47e330be-1731-f8ab-e063-6294a90aa44e
Type
HUMAN OTC DRUG
Nonproprietary name
Diaper Rash Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
GM Pharmaceuticals, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-01
Substance
ZINC OXIDE
Active strength
22 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Z-Bum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE22 g/100g

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
1734937Internal RxNorm lookup
1734942Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a36f396-3a30-3f3f-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-375-04Z-Bum113 g in 1 TUBECREAM11311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-375-04GM - Gram58809-375d54b7ea0-7525-4bc4-96d7-64b4b50a061c12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-375Z-BUM (DIAPER RASH CREAM) CREAM [GM PHARMACEUTICALS, INC]10Current NDC, Legacy NDC, 1 package rows20240328_2a36f396-3a30-3f3f-e054-00144ff8d46c.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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734942Z-Bum 22 % Topical CreamPSN2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734937zinc oxide 22 % Topical CreamPSN2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734942zinc oxide 220 MG/ML Topical Cream [Z-Bum]SBD2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734937zinc oxide 220 MG/ML Topical CreamSCD2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734942Z-Bum 22 % Topical CreamSY2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734942Z-Bum 220 MG/ML Topical CreamSY2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734937zinc oxide 22 % Topical CreamSY2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734937ZNO 220 MG/ML Topical CreamSY2a36f396-3a30-3f3f-e054-00144ff8d46c11
1734942ZNO 220 MG/ML Topical Cream [Z-Bum]SY2a36f396-3a30-3f3f-e054-00144ff8d46c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-375-0458809037504113 g in 1 TUBE (58809-375-04) 113 g2015-12-010000-00-00NoNoCurrent