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		2026-10-15
excluded package	package	70000-0546	70000-0546-7	D	Discontinued by firm		2026-10-15

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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXIMUM STRENGTH Lidocaine Plus Menthol	LIDOCAINE, MENTHOL	ARMY AND AIR FORCE EXCHANGE SERVICE	60f72061-d264-424e-b396-5a609076d352	2026-08-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	5980c527-6bcb-a846-e063-6294a90a0788	2026-08-20	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Amerisource Bergen	5fb5e5ce-b268-4444-8b63-ea7ea6abf269	2026-08-20	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	58c2b35c-e1ed-7ea8-e063-6294a90a1494	2026-08-19	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	585e740b-e4fa-d2aa-e063-6294a90a0982	2026-08-19	Warnings	Exact identifier application number: M017
Eagle Brand Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0822bcde-a8ad-be95-e063-6294a90ad208	2026-08-19	Warnings	Exact identifier application number: M017
ANTI ITCH	HYDROCORTISONE	HyVee Inc	1ab6bbb8-2b91-4c53-9168-b1e85ac296e9	2026-08-19	Warnings	Exact identifier application number: M017
hydrocortisone 1	HYDROCORTISONE	Kroger Company	f05edff2-2dc5-427c-b52c-518e0aaef4e0	2026-08-19	Warnings	Exact identifier application number: M017
MedPride	HYDROCORTISONE	Shield Line LLC	2f15d3b3-d1e6-4742-9eac-f956c0ffbba4	2026-08-18	Warnings	Exact identifier application number: M017
Pain Relieving Cream Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Garcoa, Inc.	2f736307-5cd4-4a76-9044-4aeecba096cc	2026-08-18	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll on	PAIN RELIEF ROLL ON	NeilMed Pharmaceuticals Inc	58ff9d2d-99e6-8f98-e063-6394a90a8de7	2026-08-17	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1/2%	Sun Pharmaceutical Industries, Inc.	59337940-c9be-58af-e063-6394a90abe13	2026-08-16	Warnings	Exact identifier application number: M017
SIERQ Numbing	MENTHOL	Putian Licheng District Zhijiancheng Trading Co., Ltd.	5936c070-d8e4-56e8-e063-6294a90a5600	2026-08-16	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5911d9b0-1acb-3546-e063-6294a90adb3a	2026-08-15	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	59072f05-eefa-d823-e063-6394a90a0e1a	2026-08-14	Warnings	Exact identifier application number: M017
JJ Care First Aid Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Nantong Health & Beyond Hygienic Products Inc.	c41621fb-c549-4394-a4cb-cb81ef8c98df	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Exact identifier application number: M017
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING	MENTHOL, CAMPHOR	Just Brands LLC	5384e80f-c242-76a1-e063-6294a90aba0b	2026-08-12	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