Leader Anti-Itch

Product NDC: 49781-093
11-digit product format: 497810093
Labeler code: 49781
Product ID: 49781-093_4163e89f-0469-4080-937f-d20f0ef19353
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine and Resorcinol
Dosage form: CREAM
Route: TOPICAL
Labeler: Cardinal Health
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-05-19
Marketing end: 0000-00-00
Substance: BENZOCAINE; RESORCINOL
Active strength: 50 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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	49781-093		D	Discontinued by firm		2026-10-05
excluded package	package	49781-093	49781-093-01	D	Discontinued by firm		2026-10-05

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49781-093-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49781-093-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49781-093-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49781-093-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49781-093-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49781-093-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49781-093-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49781-093-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49781-093-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49781-093-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49781-093-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49781-093-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49781-093-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49781-093-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49781-093-01	2021-03-30	C162847	48780-1	9d75b9d0-ece3-f424-e053-dadaa90a57ce	ee7298ed-e5e7-430b-bd69-baba4763f676
49781-093-01	2020-01-31	C162847	48780-1	9d75b9d0-ece3-f424-e053-dadaa90a57ce	ee7298ed-e5e7-430b-bd69-baba4763f676

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49781-093-01	GM - Gram	49781-093	10ab616d-4c2c-4331-82bc-22f9ea66fc84	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
RESORCINOL	ACTIVE INGREDIENT	YUL4LO94HK	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
RESORCINOL	ACTIVE MOIETY	YUL4LO94HK	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
.Alpha.-Tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	809Y72KV36	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Potassium Methylparaben	INACTIVE INGREDIENT	M64U971IB0	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Vitamin A	INACTIVE INGREDIENT	81G40H8B0T	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Vitamin D	INACTIVE INGREDIENT	9VU1KI44GP	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	LEADER ANTI-ITCH REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CARDINAL HEALTH]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
YUL4LO94HK	RESORCINOL	108-46-3	RESORCINOL

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader Anti-Itch Regular Strength - Cardinal Health \| Natural Essentials	Cardinal Health \| Natural Essentials	2018-01-24	HUMAN OTC DRUG LABEL	2