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		2026-10-23
excluded package	package	70000-0546	70000-0546-7	D	Discontinued by firm		2026-10-23

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 40 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving Patch	LIDOCAINE	FlexiGo Inc.	4868af2a-c4be-9c68-e063-6394a90a565b	2026-01-15	Warnings	Exact identifier application number: M017
Helocaine Cold Sore Fever Blister Treatment	TETRACAINE, MINERAL	Pagari Life Science Corp.	1b2eae09-5de0-9219-e063-6294a90af046	2026-01-15	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 Pain Relieving Gel-Patches	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	a6ca8382-7ce5-4df9-912e-8a0ac0423116	2026-01-15	Warnings	Exact identifier application number: M017
Neuropathy Cream	MENTHOL CREAM	Owell Naturals Brand, LLC	48739205-627b-41d0-e063-6394a90a3462	2026-01-15	Warnings	Exact identifier application number: M017
BLT 1	BENZOCAINE	CENTURA PHARMACEUTICALS INC	3eea2171-850b-4045-e054-00144ff8d46c	2026-01-15	Warnings	Exact identifier application number: M017
Icy Hot Lidocaine Dry	LIDOCAINE, MENTHOL	Chattem, Inc.	d500a74e-ab93-4919-8665-a89e9d4cad28	2026-01-15	Warnings	Exact identifier application number: M017
Cortizone 10 Bug Bite Relief	1% HYDROCORTISONE	Chattem, Inc.	b21b6c04-8246-4567-98cf-64e8c588e79c	2026-01-15	Warnings	Exact identifier application number: M017
Gold Bond Intensive Relief Anti-Itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Chattem, Inc.	e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone-10 Soothing Aloe Creme	HYDROCORTISONE	Chattem, Inc.	1a841bf0-9d7b-4566-b442-aa9bcc827846	2026-01-14	Warnings	Exact identifier application number: M017
Cortisone 10 Sensitive Skin Creme	HYDROCORTISONE	Chattem, Inc.	b139917c-00bb-4cb3-995d-a6d2f2c295c6	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone 10 for Psoriasis	HYDROCORTIZONE	Chattem, Inc.	fad9eedb-95e1-4e1a-91e5-0bfd077e0cf5	2026-01-14	Warnings	Exact identifier application number: M017
Pain Relief Roll On	TOPICAL ANALGESIC	Eagle Labs Inc	2380a400-062a-4a8d-a594-a2e097219044	2026-01-14	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE 4%	AvKARE	70aace2f-47b4-e961-e053-2991aa0a6367	2026-01-14	Warnings	Exact identifier application number: M017
JUST CBD - ULTRA RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	485f355a-4458-67b6-e063-6394a90ab2a0	2026-01-14	Warnings	Exact identifier application number: M017
Relief Pain Relieving Cream	MENTHOL	Corganics, LP	85814fff-35f8-447f-b669-87eaf55e9859	2026-01-14	Warnings	Exact identifier application number: M017
Mentholatum Soothing Vapor Rub Cherry	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	486269c9-af3a-7856-e063-6294a90a378c	2026-01-14	Warnings	Exact identifier application number: M017
Mentholatum Vapor Max	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	4863606f-f7c8-b4a4-e063-6294a90a1138	2026-01-14	Warnings	Exact identifier application number: M017
Hydrocortisone Cream Intensive Healing	HYDROCORTISONE CREAM	Walgreens	8a3f486c-1353-466d-9ea7-c14559b53bf3	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Cream with Aloe	HYDROCORTISONE CREAM	Walgreens	e8f69c4b-2570-477e-9c6d-d552d30ac0d0	2026-01-14	Warnings	Exact identifier application number: M017
Hydrocortisone	COOL RELIEF GEL WITH ALOE	Walgreens	1ae2b37d-d5b2-74d2-e063-6294a90a0de0	2026-01-14	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