DermacinRx Zinc Oxide Skin Healing

Product NDC: 59088-563
Requested package NDC: 59088-563-01
11-digit product format: 590880563
Labeler code: 59088
Product ID: 59088-563_2385b010-01d9-4b28-e063-6394a90ac60d
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: PureTek Corporation
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-03
Substance: ZINC OXIDE
Active strength: 200 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: DermacinRx Zinc Oxide Skin Healing
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416684	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
541b8da8-f0c1-4f57-94a7-193084d9a611	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-563-01	DermacinRx Therazole Pak	4 g in 1 PACKET	PASTE	120 g	200 mg in 1g	5
59088-563-01	DermacinRx Zinc Oxide Skin Healing	4 g in 1 PACKET	PASTE	4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59088-563	DERMACINRX THERAZOLE PAK (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE) KIT [PURETEK CORPORATION]	5	Current NDC, Legacy NDC	20241215_c47f8a9c-9c86-4068-814e-05ab2090d19e.zip
59088-563	DERMACINRX ZINC OXIDE SKIN HEALING (ZINC OXIDE) PASTE [PURETEK CORPORATION]	3	Current NDC, Legacy NDC, 1 package rows	20241004_541b8da8-f0c1-4f57-94a7-193084d9a611.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 67 of 68 · 1,344 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	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
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

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
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 20 % Topical Paste	PSN	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 0.2 MG/MG Paste	SCD	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 20 % Topical Paste	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	ZNO 0.2 MG/MG Paste	SY	c47f8a9c-9c86-4068-814e-05ab2090d19e	5
416684	zinc oxide 20 % Topical Paste	PSN	541b8da8-f0c1-4f57-94a7-193084d9a611	3
416684	zinc oxide 0.2 MG/MG Paste	SCD	541b8da8-f0c1-4f57-94a7-193084d9a611	3
416684	zinc oxide 20 % Topical Paste	SY	541b8da8-f0c1-4f57-94a7-193084d9a611	3
416684	ZNO 0.2 MG/MG Paste	SY	541b8da8-f0c1-4f57-94a7-193084d9a611	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59088-563-01	59088056301	4 g in 1 PACKET (59088-563-01)	4 g	2016-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DermacinRx Therazole Pak	PureTek Corporation	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	5
DermacinRx Zinc Oxide Skin Healing Paste (Zinc Oxide)	PureTek Corporation	2024-10-02	HUMAN OTC DRUG LABEL	3