Apeaz Ultra

Product NDC: 57483-101
11-digit product format: 574830101
Labeler code: 57483
Product ID: 57483-101_deb65546-0905-49f1-9d77-f552913387c5
Type: HUMAN OTC DRUG
Nonproprietary name: camphor (synthetic), menthol, and methyl salicylate cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Innovus Pharmaceuticals, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-02-05
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength: 4 mg/g; 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	57483-101		I	Inactivated by FDA		2026-10-16
excluded package	package	57483-101	57483-101-01	I	Inactivated by FDA		2026-10-16

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 · 12 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
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	57483-101-01	`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	57483-101-01	`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	57483-101-01	`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	57483-101-01	`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	57483-101-01	`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	57483-101-01	`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
57483-101-01	2023-01-27	C162847	48780-1	9d75b9d0-ed3d-f424-e053-dadaa90a57ce	Apeaz Ultra
57483-101-01	2020-01-31	C162847	48780-1	9d75b9d0-ed3d-f424-e053-dadaa90a57ce	Apeaz Ultra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57483-101-01	Apeaz Ultra	1 in 1 CARTON	CREAM	1		4
57483-101-01	Apeaz Ultra	56.7 g in 1 CONTAINER	CREAM	56.7		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57483-101	APEAZ ULTRA (CAMPHOR (SYNTHETIC), MENTHOL, AND METHYL SALICYLATE CREAM) CREAM [INNOVUS PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20241228_ec93ca9d-ef59-456f-ac08-d50936f70424.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2474491	Apeaz Ultra 4 % / 7.5 % / 10 % Topical Cream	PSN	ec93ca9d-ef59-456f-ac08-d50936f70424	4
1998770	camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical Cream	PSN	ec93ca9d-ef59-456f-ac08-d50936f70424	4
2474491	camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical Cream [Apeaz]	SBD	ec93ca9d-ef59-456f-ac08-d50936f70424	4
1998770	camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	ec93ca9d-ef59-456f-ac08-d50936f70424	4
2474491	Apeaz Ultra (camphor 4 % / menthol 7.5 % / methyl salicylate 10 % ) Topical Cream	SY	ec93ca9d-ef59-456f-ac08-d50936f70424	4
1998770	camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical Cream	SY	ec93ca9d-ef59-456f-ac08-d50936f70424	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
57483-101-01	57483010101	1 in 1 CARTON	Historical