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 25 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoTape	LIDOCAINE 4%	V2 Pharma LLC	ed18b4f7-6a2c-4dce-9b53-e485569093c5	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	4f11aa1e-de53-a3b0-e063-6294a90a2fe4	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare 2X Medicated Pain Relief	LIDOCAINE, MENTHOL	Veridian Healthcare	4f11fca1-1949-ab8e-e063-6394a90ac627	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	4f125062-af89-40d3-e063-6394a90a27ef	2026-04-09	Warnings	Exact identifier application number: M017
DRMITSUI ECZEMA RELIEF	HYDROCORTISONE 1% ECZEMA RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4eee7637-3a28-e0bd-e063-6294a90ae1a4	2026-04-08	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR	Sinsin Pharmaceutical Co., Ltd.	47c077c2-6e34-8e7a-e063-6294a90a21b5	2026-04-08	Warnings	Exact identifier application number: M017
Yi Tiao Gen Pain Patch	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	4828fe70-f6f8-45e4-9c9a-a9e486dc65e5	2026-04-07	Warnings	Exact identifier application number: M017
Dermatool Nerve Care	LIDOCAINE HCL, MENTHOL	Papalo Group, LLC	4ee40c96-9350-4c68-e063-6294a90ac812	2026-04-07	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Pain Relieving Topical Analgesic	MENTHOL	Phoenix Bioperformance Products LLC	bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Anti-Inflammatory and Pain Relief	MENTHOL	Phoenix Bioperformance Products LLC	39a6d26b-b5f4-45d7-a9b5-6edbf42d7500	2026-04-06	Warnings	Exact identifier application number: M017
Dr. Blue PainZaway Pain Relieving Roll-On	MENTHOL	Indiana Botanic Gardens	4ecc8241-5a87-2f45-e063-6294a90aa30a	2026-04-06	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	CVS Pharmacy, Inc.	d7f52394-5cc1-48a6-ae89-9fc63b515758	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M017
Pain-Relieving Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4ecf4a6e-5c0f-7943-e063-6394a90a81cc	2026-04-06	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	RAPID AID VIET NAM COMPANY LIMITED	4edbaa1a-6e44-4865-e063-6394a90a8cc3	2026-04-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1% Cream	CAPSAICIN 0.1%	Puretek Corporation	4e83441b-cb6a-beb0-e063-6394a90a1b54	2026-04-03	Warnings	Exact identifier application number: M017
NeroCare Capsaicin Neuropathy Relief Cream	CAPSAICIN	Guangzhou Tata Biotechnology Co., Ltd.	4e89b7eb-0d84-dc57-e063-6394a90a7dd9	2026-04-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Patch	LIDOCAINE 4%	Veridian Healthcare	4e91da65-8191-6261-e063-6394a90a6bd5	2026-04-03	Warnings	Exact identifier application number: M017
HealthWise Roll-On	LIDOCAINE, MENTHOL	Veridian Healthcare	4e9306b5-949e-f7a9-e063-6394a90ae13a	2026-04-03	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