Anti Itch Balm

Product NDC: 57285-100
11-digit product format: 572850100
Labeler code: 57285
Product ID: 57285-100_7aff6e22-67f3-408c-adcc-e2978f1c1508
Type: HUMAN OTC DRUG
Nonproprietary name: Peppermint Oil
Dosage form: OINTMENT
Route: TOPICAL
Labeler: US ORGANIC GROUP CORP
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2013-03-29
Marketing end: 0000-00-00
Substance: PEPPERMINT OIL
Active strength: 0 g/28g
NDC exclude flag: E
Listing certified through: 2017-12-31
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	57285-100		I	Inactivated by FDA		2026-08-03
excluded package	package	57285-100	57285-100-02	I	Inactivated by FDA		2026-08-03

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 · 44 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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`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	57285-100-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57285-100-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57285-100-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57285-100-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57285-100-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57285-100-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57285-100-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57285-100-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57285-100-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57285-100-02	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57285-100-02	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57285-100-02	2019-11-27	C162847	48780-1	9855d018-ed2c-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57285-100-01	Anti Itch Balm	28 g in 1 JAR	OINTMENT	28		3
57285-100-02	Anti Itch Balm	1 in 1 CARTON	OINTMENT	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Peppermint Oil	ACTIVE INGREDIENT	AV092KU4JH	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
Peppermint	ACTIVE MOIETY	V95R5KMY2B	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
ACHILLEA MILLEFOLIUM	INACTIVE INGREDIENT	2FXJ6SW4PK	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
CHAMAEMELUM NOBILE FLOWER OIL	INACTIVE INGREDIENT	UB27587839	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
EVENING PRIMROSE OIL	INACTIVE INGREDIENT	3Q9L08K71N	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
FRANKINCENSE OIL	INACTIVE INGREDIENT	67ZYA5T02K	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
TAMANU OIL	INACTIVE INGREDIENT	JT3LVK84A1	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57285-100	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3	Legacy NDC, 2 package rows	20130329_c0cb1412-8a46-4f41-9162-10e6f7237ef9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AV092KU4JH	PEPPERMINT OIL	8006-90-4	PEPPERMINT OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373452	peppermint oil 0.34 % Topical Ointment	PSN	c0cb1412-8a46-4f41-9162-10e6f7237ef9	3
1373452	peppermint oil 0.0034 MG/MG Topical Ointment	SCD	c0cb1412-8a46-4f41-9162-10e6f7237ef9	3
1373452	peppermint oil 0.34 % Topical Ointment	SY	c0cb1412-8a46-4f41-9162-10e6f7237ef9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57285-100-01	57285010001	28 g in 1 JAR	28 g	Historical
57285-100-02	57285010002	1 in 1 CARTON		Historical