Leader Anti-Itch

Product NDC: 70000-0546
11-digit product format: 700000546
Labeler code: 70000
Product ID: 70000-0546_43fa4c6d-3b73-48ab-e063-6394a90ae0f4
Type: HUMAN OTC DRUG
Nonproprietary name: Camphor, Menthol
Dosage form: LOTION
Route: TOPICAL
Labeler: LEADER/Cardinal Helath 110, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-21
Substance: CAMPHOR (SYNTHETIC); MENTHOL
Active strength: .5; .5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70000-0546		D	Discontinued by firm		2026-10-21
excluded package	package	70000-0546	70000-0546-7	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0546-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0546-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70000-0546-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70000-0546-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70000-0546-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70000-0546-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70000-0546-7	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70000-0546-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70000-0546-7	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70000-0546-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70000-0546-7	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70000-0546-7	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Anti-Itch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAMPHOR (SYNTHETIC)	.5 g/100g
MENTHOL	.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5TJD82A1ET	Internal UNII lookup
L7T10EIP3A	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
9ca985c6-5017-0558-e053-2995a90a8202	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70000-0546-1	2024-01-04	C162847	48780-1	f386c64a-37ea-0266-e053-dadaa90a7c1a	Leader Original Anti Itch Lotion
70000-0546-1	2023-01-30	C162847	48780-1	f386c64a-37ea-0266-e053-dadaa90a7c1a	Leader Original Anti Itch Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0546-1	Leader Anti-Itch	212 g in 1 BOTTLE, PUMP	LOTION	212		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0546-1	ML - Milliliter	70000-0546	b2398c74-4403-44a7-90c3-99f5bae4f75a	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0546	LEADER ANTI-ITCH (CAMPHOR, MENTHOL) LOTION [LEADER/CARDINAL HELATH 110, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20241208_9ca985c6-5017-0558-e053-2995a90a8202.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 31 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride and Zinc Acetate	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	STRATEGIC SOURCING SERVICES LLC	ec0c9602-35cc-4bb6-b853-794a8b5bf42e	2026-03-03	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE 1%	PHARMACY CHOICE INC	4cdfe8b6-c332-7bf8-e063-6394a90abaec	2026-03-03	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	4c06c4a4-557b-8bb1-e063-6294a90a9125	2026-03-02	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Old East Main Co.	49173ec8-c94a-44c9-8a13-0f4b01b96cd6	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Old East Main Co.	6d87547f-bf4c-4dda-bd9d-32b576afd805	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M017
Still Standing	MENTHOL, UNSPECIFIED FORM	Natural Essentials Inc.	66974aaf-c82f-4fe9-bfb3-3430b80ac9f2	2026-03-02	Warnings	Exact identifier application number: M017
Lightning Pain Relief	MENTHOL	Clinical Resolution Laboratory, Inc.	80af21f5-dba8-42b0-8a65-ac5a94d83ca8	2026-03-02	Warnings	Exact identifier application number: M017
Icy Hot Lidocaine No-Mess	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	347f9a18-8ab6-47d3-9610-5b4e9ca5d53a	2026-03-02	Warnings	Exact identifier application number: M017
Gold Bond Maximum Strength Foot Pain Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	8e469076-2f5a-4de8-8d13-a38c072b9af8	2026-03-01	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	48ecbab9-13e0-d0fa-e063-6294a90a6ff2	2026-02-28	Warnings	Exact identifier application number: M017
NUMBING CREAMS	LIDOCAINE	Yongchun Lihui Trading Co., Ltd.	3b5e1a74-5946-4f1f-e063-6394a90a404b	2026-02-27	Warnings	Exact identifier application number: M017
Pain Relieving Gel	LIDOCAINE HYDROCHLORIDE	Chain Drug Marketing Association	b55b7253-2fd2-45cc-b94c-e92395ab0d2b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M017
MEDISTIK PROFESSIONAL DUAL ACTION	MENTHOL, METHYL SALICYLATE, EUCALUPTUS	Natureteq Inc.	99c7f08a-ab14-4371-9147-189f75cb6633	2026-02-27	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Walmart Inc.	309dcf5b-7166-976a-e063-6394a90af952	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M017
ASYSTEM Radical Relief Gel Roll-On	MENTHOL, METHYL SALICYLATE	Cosco International, Inc.	7239733e-5510-4a63-96c3-dd88b4a431a3	2026-02-27	Warnings	Exact identifier application number: M017
Icy Hot Pro Pain Massaging Balm	CAMPHOR AND MENTHOL	Chattem, Inc.	09e2b0cb-5186-4f9c-b256-edaced4ca014	2026-02-27	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE PAIN RELIEF	PAI Holdings, LLC dba PAI Pharma	963978de-8295-47ee-9b06-64c3521aa994	2026-02-26	Warnings	Exact identifier application number: M017
Tommie Copper Cooling Roller Lavender Scent	MENTHOL 4%	Tommie Copper, Inc.	4bbfd4d1-9036-bc20-e063-6394a90a3feb	2026-02-26	Warnings	Exact identifier application number: M017
HQLSEY QUIT SMOKING PATCHES	QUIT SMOKING PATCHES	Hansen Pharmaceutical Investment Co., Limited	4ba317fb-714a-05cb-e063-6394a90a382f	2026-02-25	Warnings	Exact identifier application number: M017
Advanced Pain Relief Cream With 5 % Natural Menthol	MENTHOL	Allure Labs	4bab9c43-86d4-dad2-e063-6394a90ac095	2026-02-25	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0546-1	70000054601	212 g in 1 BOTTLE, PUMP (70000-0546-1)	212 g	2020-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader Original Anti Itch Lotion	LEADER/Cardinal Helath 110, Inc. \| Weeks & Leo Co., Inc. \| Weeks & Leo	2025-11-19	HUMAN OTC DRUG LABEL	7
Leader Original Anti Itch Lotion	CARDINAL HEALTH \| Weeks & Leo Co., Inc. \| Weeks & Leo	2023-02-08	HUMAN OTC DRUG LABEL	4