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 32 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Pain Relieving Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE	Walgreen Co.	4223c74a-12fb-51a3-e063-6294a90a0deb	2026-02-25	Warnings	Exact identifier application number: M017
Advanced Pain Relief Roll-On Gel With 5% Natural Menthol	MENTHOL	Allure Labs	4bad597f-acb2-a122-e063-6394a90a9fcf	2026-02-25	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	4bade8a9-43bd-b649-e063-6294a90a81da	2026-02-25	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Strength	MENTHOL	EX Healthcare Inc.	4620c41a-2187-00f5-e063-6394a90a613c	2026-02-23	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Sculpt	MENTHOL	EX Healthcare Inc.	4620d4ca-42e4-eeae-e063-6394a90a5c84	2026-02-23	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Extra Strength	MENTHOL	EX Healthcare Inc.	4620ca7a-afe6-d063-e063-6394a90ab5db	2026-02-23	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	9578b39e-3df7-4d75-abd7-f1d5524545e5	2026-02-23	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	cf723c7b-495d-4bae-942c-561cf28af2d3	2026-02-21	Warnings	Exact identifier application number: M017
Swiftalyn Numbing Cream	MENTHOL 1%	GENUINE INNOVATION LTD	4b2ebff2-2f50-e54b-e063-6294a90aaccb	2026-02-19	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving	MENTHOL	Walmart Inc	46a3c9e9-5cd3-4bc4-e063-6394a90a7178	2026-02-19	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Meijer, Inc.	e11390ec-99a3-4ff1-a3c8-ca909f4f67b5	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Meijer, Inc.	d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4b1a0e6f-aa68-421c-e063-6294a90a426e	2026-02-18	Warnings	Exact identifier application number: M017
Veiurkiu External Analgesic Cream	LIDOCAINE	BLOOMWELL GARDENS LLC	40ec5e6f-13dc-de04-e063-6294a90af5d5	2026-02-18	Warnings	Exact identifier application number: M017
External Analgesic Cream with Menthol 5%	MENTHOL 5%	BLOOMWELL GARDENS LLC	402faa27-5305-c73d-e063-6394a90a36f2	2026-02-18	Warnings	Exact identifier application number: M017
PAINGEL	MENTHOL, METHYL SALICYLATE	NACOR BUSINESS GROUP LLC	4b1d55e2-cf83-ffbd-e063-6294a90ad52f	2026-02-18	Warnings	Exact identifier application number: M017
Alocane Anti-Itch	HYDROCORTISONE 1%	Quest Products, LLC	45252043-d41a-3cdd-e063-6394a90aa9e5	2026-02-18	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Medrock Pharmacy LLC	43e00e17-1a48-43db-9589-834568917bbf	2026-02-17	Warnings	Exact identifier application number: M017
Tylenol Precise Cooling Pain Relieving	LIDOCAINE, MENTHOL	Kenvue Brands LLC	fc0a3404-b174-3952-e053-6294a90a1e02	2026-02-16	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL	Valu Merchandisers Company	87ee2b4f-d640-4cec-9f48-1d8aa54434e9	2026-02-16	Warnings, Adverse reactions	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