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
Ingredient	Strength
ZINC OXIDE	22 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734937	Internal RxNorm lookup
1734942	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2a36f396-3a30-3f3f-e054-00144ff8d46c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-375-04	Z-Bum	113 g in 1 TUBE	CREAM	113		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-375-04	GM - Gram	58809-375	d54b7ea0-7525-4bc4-96d7-64b4b50a061c	1	2016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-375	Z-BUM (DIAPER RASH CREAM) CREAM [GM PHARMACEUTICALS, INC]	10	Current NDC, Legacy NDC, 1 package rows	20240328_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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChapStick Classic Spearmint	PETROLATUM	Haleon US Holdings LLC	d39786e8-bcd8-479d-8990-142a21788a47	2024-04-12	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	d6eb2ea6-27c7-40a6-a1f0-789ea2131de3	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Active 2in1 Variety Pack	ZINC OXIDE	Haleon US Holdings LLC	d1998a9e-d61f-4b4c-91b0-5e66754bcc4a	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	040694f0-b5ba-4203-bde9-699fa9b1afef	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Holiday Classics Kit	WHITE PETROLATUM	Haleon US Holdings LLC	6df216dc-c03d-463a-8029-5e54c1dc3d27	2024-04-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula	OCTINOXATE, OXYBENZONE, WHITE PETROLATUM	Carma Laboratories, Inc.	3eb0f8ff-89e7-4410-8573-3349e4946548	2024-04-02	Warnings	Exact identifier application number: M016
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier application number: M016
ChapStick Supreme Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	84d8cc38-83e3-49be-b180-d01820525b60	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	9cd13fbb-887f-46a8-9f0b-4450ad3e07b7	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Peachy Keen	ZINC OXIDE	Haleon US Holdings LLC	ef206fe7-2659-41dc-b117-380af704999b	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Pretty in Pink	ZINC OXIDE	Haleon US Holdings LLC	e686ce23-57bc-4026-be62-d46d90ded442	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Very Berry	ZINC OXIDE	Haleon US Holdings LLC	59023150-65ef-4427-9045-0e64b100cbab	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	33497c07-ad6e-4c50-bc23-a55725b2eae1	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5	2024-03-21	Warnings	Exact identifier application number: M016
ChapStick Classic Strawberry	WHITE PETROLATUM	Haleon US Holdings LLC	3a279496-74c5-4ab1-ba69-06ad4a4f67cf	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74	2024-03-21	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Sore Relief Kit	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	523b6598-8039-4116-b0f8-ba31d7d6ea9d	2024-03-20	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	db041b1b-084a-4283-b6ba-4d4bcdc220b3	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Original	WHITE PETROLATUM	Haleon US Holdings LLC	42fe0f4a-efb7-4e70-a359-db7dc2ac9905	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	WHITE PETROLATUM	Haleon US Holdings LLC	74354d8e-c265-4a27-9715-1a4c157ad890	2024-03-19	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734942	Z-Bum 22 % Topical Cream	PSN	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734937	zinc oxide 22 % Topical Cream	PSN	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734942	zinc oxide 220 MG/ML Topical Cream [Z-Bum]	SBD	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734937	zinc oxide 220 MG/ML Topical Cream	SCD	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734942	Z-Bum 22 % Topical Cream	SY	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734942	Z-Bum 220 MG/ML Topical Cream	SY	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734937	zinc oxide 22 % Topical Cream	SY	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734937	ZNO 220 MG/ML Topical Cream	SY	2a36f396-3a30-3f3f-e054-00144ff8d46c	11
1734942	ZNO 220 MG/ML Topical Cream [Z-Bum]	SY	2a36f396-3a30-3f3f-e054-00144ff8d46c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-375-04	58809037504	113 g in 1 TUBE (58809-375-04)	113 g	2015-12-01	0000-00-00	No	No	Current