SUDOCREM SKIN PROTECTANT

Product NDC: 84589-002
11-digit product format: 845890002
Labeler code: 84589
Product ID: 84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: LEDA INNOVATIONS USA, INC.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-06
Substance: ZINC OXIDE
Active strength: 152.9 mg/g
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: SUDOCREM SKIN PROTECTANT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	152.9 mg/g

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
20d2cf0b-d237-fd78-e063-6394a90a8d03	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84589-002-10	SUDOCREM SKIN PROTECTANT	1 in 1 BLISTER PACK	CREAM	1	1
84589-002-10	SUDOCREM SKIN PROTECTANT	10 g in 1 JAR	CREAM	10	1
84589-002-12	SUDOCREM SKIN PROTECTANT	125 g in 1 JAR	CREAM	125	1
84589-002-25	SUDOCREM SKIN PROTECTANT	250 g in 1 JAR	CREAM	250	1
84589-002-40	SUDOCREM SKIN PROTECTANT	400 g in 1 JAR	CREAM	400	1
84589-002-60	SUDOCREM SKIN PROTECTANT	60 g in 1 JAR	CREAM	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84589-002	SUDOCREM SKIN PROTECTANT (ZINC OXIDE) CREAM [LEDA INNOVATIONS USA, INC.]	1	Current NDC, 6 package rows	20240830_20d2cf0b-d237-fd78-e063-6394a90a8d03.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84589-002-10	84589000210	1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR	1 jar	2024-08-06	No	No	Current
84589-002-12	84589000212	125 g in 1 JAR (84589-002-12)	125 g	2024-08-06	No	No	Current
84589-002-25	84589000225	250 g in 1 JAR (84589-002-25)	250 g	2024-08-06	No	No	Current
84589-002-40	84589000240	400 g in 1 JAR (84589-002-40)	400 g	2024-08-06	No	No	Current
84589-002-60	84589000260	60 g in 1 JAR (84589-002-60)	60 g	2024-08-06	No	No	Current