ULTRACIN

Product NDC: 55628-9179
11-digit product format: 556289179
Labeler code: 55628
Product ID: 55628-9179_5a65d914-36ab-4ffe-874f-4b46b2c21441
Type: HUMAN OTC DRUG
Nonproprietary name: METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form: LOTION
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; METHYL SALICYLATE; CAPSAICIN
Active strength: 10 g/100mL; g/100mL; mg/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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55628-9179		D	Discontinued by firm	2026-08-03
excluded package	package	55628-9179	55628-9179-1	D	Discontinued by firm	2026-08-03
excluded package	package	55628-9179	55628-9179-2	D	Discontinued by firm	2026-08-03
excluded package	package	55628-9179	55628-9179-4	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 2 · 64 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	55628-9179-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55628-9179-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55628-9179-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55628-9179-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55628-9179-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55628-9179-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55628-9179-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55628-9179-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55628-9179-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55628-9179-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55628-9179-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55628-9179-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55628-9179-1	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	55628-9179-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55628-9179-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55628-9179-1	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	55628-9179-4	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55628-9179-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55628-9179-2	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	55628-9179-4	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55628-9179-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55628-9179-2	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	55628-9179-4	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55628-9179-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55628-9179-2	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55628-9179-1	2024-04-01	3b0612ee-95e2-42f5-b671-00029bb5da95
55628-9179-2	2024-04-01	3b0612ee-95e2-42f5-b671-00029bb5da95
55628-9179-4	2024-04-01	3b0612ee-95e2-42f5-b671-00029bb5da95
55628-9179-1	2022-01-28	3b0612ee-95e2-42f5-b671-00029bb5da95
55628-9179-2	2022-01-28	3b0612ee-95e2-42f5-b671-00029bb5da95
55628-9179-4	2022-01-28	3b0612ee-95e2-42f5-b671-00029bb5da95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55628-9179-1	ML - Milliliter	55628-9179	d9ba2c9a-e08f-4cd6-9ef2-5bde9b4b373d	1	2015-01-05
55628-9179-2	ML - Milliliter	55628-9179	fbd4a6d3-bd0e-4ee6-b123-8811cbfe4464	1	2015-05-05
55628-9179-4	ML - Milliliter	55628-9179	934dac92-e1db-4cc6-8e4d-cb86250a1b2a	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
GAULTHERIA PROCUMBENS LEAF	INACTIVE INGREDIENT	2125M16OWN	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
INDIAN FRANKINCENSE	INACTIVE INGREDIENT	4PW41QCO2M	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
MARITIME PINE	INACTIVE INGREDIENT	50JZ5Z98QY	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
POLOXAMER 124	INACTIVE INGREDIENT	1S66E28KXA	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
TUSSILAGO FARFARA LEAF	INACTIVE INGREDIENT	G2GH7V846Z	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
WILLOW BARK	INACTIVE INGREDIENT	S883J9JDYX	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ZANTHOXYLUM AMERICANUM BARK	INACTIVE INGREDIENT	A4KL1HMZ7T	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ZANTHOXYLUM BUNGEANUM WHOLE	INACTIVE INGREDIENT	WH9894JM8K	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4
ZINGIBER OFFICINALE WHOLE	INACTIVE INGREDIENT	IN6Q3S3414	ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55628-9179-1	55628917901	30 mL in 1 TUBE (55628-9179-1)	30 ml	2012-11-29	0000-00-00	No	No	Current
55628-9179-2	55628917902	60 mL in 1 BOTTLE (55628-9179-2)	60 ml	2012-11-29	0000-00-00	No	No	Current
55628-9179-4	55628917904	120 mL in 1 TUBE (55628-9179-4)	120 ml	2012-11-29	0000-00-00	No	No	Current