ULTRACIN M

Product NDC: 55628-9051
11-digit product format: 556289051
Labeler code: 55628
Product ID: 55628-9051_a14aadef-9153-4018-b9b1-f08006e6be76
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Cal Pharma
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-11-29
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 10 g/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	55628-9051		D	Discontinued by firm		2026-08-03
excluded package	package	55628-9051	55628-9051-4	D	Discontinued by firm		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 · 32 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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	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	55628-9051-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55628-9051-4	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55628-9051-4	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55628-9051-4	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55628-9051-4	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55628-9051-4	2024-04-01	C162847	48780-1	d6a99b39-9f3d-a426-e053-dadaa90af4c2	4ff54f99-5eec-4209-932e-3ad076309c52
55628-9051-4	2022-01-28	C162847	48780-1	d6a99b39-9f3d-a426-e053-dadaa90af4c2	4ff54f99-5eec-4209-932e-3ad076309c52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55628-9051-4	ML - Milliliter	55628-9051	c6ab4dbc-e291-4331-8d54-90396aeb9049	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
ARNICA MONTANA FLOWER WATER	INACTIVE INGREDIENT	U7L2JP51PR	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
BOSWELLIA SERRATA WHOLE	INACTIVE INGREDIENT	X7B7P649WQ	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
GAULTHERIA PROCUMBENS LEAF	INACTIVE INGREDIENT	2125M16OWN	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
LIME (CITRUS)	INACTIVE INGREDIENT	8CZS546954	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
MARITIME PINE	INACTIVE INGREDIENT	50JZ5Z98QY	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
PETASITES JAPONICUS ROOT	INACTIVE INGREDIENT	6F650HF10T	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
SALIX NIGRA BARK	INACTIVE INGREDIENT	QU52J3A5B3	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
ZANTHOXYLUM AMERICANUM BARK	INACTIVE INGREDIENT	A4KL1HMZ7T	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1
ZANTHOXYLUM BUNGEANUM FRUIT	INACTIVE INGREDIENT	3CIP16A418	ULTRACIN M (MENTHOL) GEL [CAL PHARMA]	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55628-9051-4	55628905104	120 mL in 1 BOTTLE (55628-9051-4)	120 ml	2012-11-29	0000-00-00	No	No	Current