Balmex Diaper Rash

Product NDC: 52412-285
11-digit product format: 524120285
Labeler code: 52412
Product ID: 52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide 11.3%
Dosage form: CREAM
Route: TOPICAL
Labeler: Randob Labs, LTD
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-19
Substance: ZINC OXIDE
Active strength: 11.3 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Balmex Diaper Rash
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	11.3 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
630923	Internal RxNorm lookup
967558	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
f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52412-285-02	Balmex Diaper Rash	1 in 1 CARTON	CREAM	1	3
52412-285-02	Balmex Diaper Rash	56 g in 1 TUBE	CREAM	56	3
52412-285-03	Balmex Diaper Rash	85 g in 1 TUBE	CREAM	85	3
52412-285-03	Balmex Diaper Rash	1 in 1 CARTON	CREAM	1	3
52412-285-04	Balmex Diaper Rash	1 in 1 CARTON	CREAM	1	3
52412-285-04	Balmex Diaper Rash	113 g in 1 TUBE	CREAM	113	3
52412-285-12	Balmex Diaper Rash	340 g in 1 JAR	CREAM	340	3
52412-285-16	Balmex Diaper Rash	453 g in 1 JAR	CREAM	453	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52412-285	BALMEX DIAPER RASH (ZINC OXIDE 11.3%) CREAM [RANDOB LABS, LTD]	3	Current NDC, 8 package rows	20241217_f7f7a89d-d4e0-9faa-e053-6294a90aaf7b.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	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
967558	Balmex 11.3 % Topical Cream	PSN	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
630923	zinc oxide 11.3 % Topical Cream	PSN	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
967558	zinc oxide 113 MG/ML Topical Cream [Balmex]	SBD	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
630923	zinc oxide 113 MG/ML Topical Cream	SCD	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
967558	Balmex 11.3 % Topical Cream	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
967558	Balmex 113 MG/ML Topical Cream	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
967558	Balmex Diaper Rash Cream Stick	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
630923	zinc oxide 11.3 % Topical Cream	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
630923	ZNO 113 MG/ML Topical Cream	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3
967558	ZNO 113 MG/ML Topical Cream [Balmex]	SY	f7f7a89d-d4e0-9faa-e053-6294a90aaf7b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52412-285-02	52412028502	1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE	1 tube	2021-04-19	No	No	Current
52412-285-03	52412028503	1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE	1 tube	2023-04-04	No	No	Current
52412-285-04	52412028504	1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE	1 tube	2021-04-19	No	No	Current
52412-285-12	52412028512	340 g in 1 JAR (52412-285-12)	340 g	2021-04-19	No	No	Current
52412-285-16	52412028516	453 g in 1 JAR (52412-285-16)	453 g	2021-04-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Balmex Diaper Rash Cream	Randob Labs, LTD \| Derma Care Research Labs	2024-12-15	HUMAN OTC DRUG LABEL	3