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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact 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