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 24 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriDerma Stubborn Diaper Rash ReliefALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporationf8f3ae0b-aa55-4c2f-8823-54268524917b2026-01-28WarningsExact identifier
application number: M016
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M016
Equate Chafing GelDIMETHICONEWalmart Inc06665504-040c-a806-e063-6294a90acedc2026-01-27WarningsExact identifier
application number: M016
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
application number: M016
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
application number: M016
XIMONTH Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49451717-e41c-8ae0-e063-6294a90a91ad2026-01-26WarningsExact identifier
application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated SoakALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.09a178c1-0eb1-43e5-bde8-fd27ed633d592026-01-26WarningsExact identifier
application number: M016
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
application number: M016
HydrocortisoneDRS. HYDROCORTISONEOL PHARMA TECH,LLCb0eac8f3-bb80-6563-e053-2995a90a83c92026-01-22WarningsExact identifier
application number: M016
Eczema Reliegf Skin Protectant EQBCOLLOIDAL OATMEAL 2%Walmart37132a0d-37c5-4b21-9673-5f853b3a62482026-01-20WarningsExact identifier
application number: M016
Skin Relief CreamHYDROCORTISONESpa de Soleil0a90b77a-4be4-71c5-e063-6294a90a8e412026-01-20WarningsExact identifier
application number: M016
Cold Sore BandageCOLD SORE BANDAGEShenzhen Hengdasheng Technology Co., Ltd47f588a2-a69b-cffe-e063-6294a90a0ed42026-01-17WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.48793a50-89a7-dba9-e063-6394a90a70562026-01-16WarningsExact identifier
application number: M016
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
application number: M016
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKINDIMETHICONESolvChem, Inc.da12ac2c-1af9-47b1-aa5f-77acb48535ba2026-01-16WarningsExact identifier
application number: M016
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
application number: M016
INCONTINENCE CARE WIPEDIMETHICONECardinal Health 200, Inc.1ac34c94-9e3b-45f2-ba19-a07dcd3941dd2026-01-15WarningsExact identifier
application number: M016
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
application number: M016
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact 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