Leader Zinc Oxide

Product NDC: 70000-0334
11-digit product format: 700000334
Labeler code: 70000
Product ID: 70000-0334_4e63f6a0-1c7c-47df-b503-1b9cf3797f9c
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Cardinal Health 110,Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-29
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: Leader Zinc Oxide
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
198911	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
4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0334-1	Leader Zinc Oxide	454 g in 1 JAR	OINTMENT	454		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0334-1	GM - Gram	70000-0334	720ca912-e7e9-4858-ae4f-0471ef0eb7e6	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0334	LEADER ZINC OXIDE (ZINC OXIDE) OINTMENT [CARDINAL HEALTH 110,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240119_4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1.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 98 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Cherry 30ct	MENTHOL	RL Albert & Son Inc.	92c54c53-c8bb-4576-abae-715a2f3878bf	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol 80ct	MENTHOL	RL Albert & Son Inc.	c96cc162-5908-4990-9dc1-3ce912844274	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry 30ct	MENTHOL	R.L. ALBERT & SON, INC	bac77712-6197-4b30-a5f8-9b99eb9d7b5a	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry 80ct	MENTHOL	R.L. ALBERT & SON, INC	6842d766-ade6-40b2-831b-f4feac25c6db	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry 80ct	MENTHOL	RL Albert & Son Inc.	9f324ca1-0e2a-47e3-997e-2aaa68a85751	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ct	MENTHOL	R.L. ALBERT & SON, INC	2063a013-aa0b-465d-b04f-cfe2e70d749f	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ct	MENTHOL	R.L. ALBERT & SON, INC	cd81488c-74d8-48d9-9c73-ff662a5cd4cd	2025-10-08	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ct	MENTHOL	R.L. ALBERT & SON, INC	61deea94-d0a9-4563-926b-53f255a7c425	2025-10-08	Warnings	Exact identifier application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS	MENTHOL	R.L. ALBERT & SON, INC	c6b36350-386b-4346-bef0-a37ec11319c0	2025-10-08	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	3314b174-d5bb-4843-9288-9b9c5fce79d5	2025-10-08	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	407b7cbb-7ebd-7b7e-e063-6394a90af501	2025-10-06	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc	2025-10-06	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	2b19fdd2-8088-47f2-be20-f220a6b825fc	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	40802fb6-c1ec-d7b0-e063-6394a90ab423	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	3f64c81a-bbfc-4575-e063-6294a90a6ed7	2025-10-06	Warnings	Exact identifier application number: M012
TexaClear Severe Cough, Cold and Flu	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GM Pharmaceuticals, INC	cb99e5b3-1908-43c9-b31f-d35e7ce58b44	2025-10-06	Warnings	Exact identifier application number: M012
RoboHBr Cough SUPPRESSANT	DEXTROMETHORPHAN HBR	DXM Pharmaceutical, Inc	0af624ce-191f-45e1-882b-e8acb90cc77b	2025-10-06	Warnings	Exact identifier application number: M012
RoboTablets	DEXTROMETHORPHAN	DXM Pharmaceutical, Inc	b92cf698-032d-4d8d-b19c-456c6338b094	2025-10-06	Warnings	Exact identifier application number: M012
SinuLief	LORATADINE	RoseWell Pharmaceuticals LLC	32619143-a782-3497-e063-6394a90aaaec	2025-10-06	Warnings	Exact identifier application number: M012
STAHIST AD	CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Magna Pharmaceuticals, Inc.	ccedbc38-2479-4c35-9f86-a9f29bcfab3f	2025-10-03	Warnings	Exact identifier application number: M012

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
198911	zinc oxide 20 % Topical Ointment	PSN	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	3
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	3
198911	zinc oxide 20 % Topical Ointment	SY	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	3
198911	zinc oxide 200 MG per GM Topical Ointment	SY	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	3
198911	ZNO 0.2 MG/MG Topical Ointment	SY	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0334-1	70000033401	454 g in 1 JAR (70000-0334-1)	454 g	2019-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader Zinc Oxide - Cardinal Health 110,Inc.	Cardinal Health 110,Inc.	2024-01-18	HUMAN OTC DRUG LABEL	3