Mata Balm

Product NDC: 58167-112
11-digit product format: 581670112
Labeler code: 58167
Product ID: 58167-112_635414da-adef-4eac-be68-daf3f35f892e
Type: HUMAN OTC DRUG
Nonproprietary name: Camphor, Menthol
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Amata LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-04-27
Marketing end: 0000-00-00
Substance: CAMPHOR (NATURAL); MENTHOL
Active strength: 45 mg/g; mg/g
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	58167-112		I	Inactivated by FDA		2026-10-05
excluded package	package	58167-112	58167-112-30	I	Inactivated by FDA		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 · 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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`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	58167-112-30	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
22bca8fc-c2b1-897d-b515-117a7522ccae	Product name	3	20150731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58167-112-30	2019-11-27	C162847	48780-1	9855d018-e18f-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58167-112-30	Mata Balm	1 in 1 BOX	OINTMENT	1		2
58167-112-30	Mata Balm	30 g in 1 JAR	OINTMENT	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
BARLERIA PRIONITIS WHOLE	INACTIVE INGREDIENT	8GSN1J79JM	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
CAJANUS CAJAN LEAF	INACTIVE INGREDIENT	DP2IW63584	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
CRINUM ASIATICUM WHOLE	INACTIVE INGREDIENT	4A0W54S52I	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
IPOMOEA PES-CAPRAE FLOWERING TOP	INACTIVE INGREDIENT	0SJ345C829	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
PIPER BETLE LEAF	INACTIVE INGREDIENT	NT24A1359E	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
QUININE	INACTIVE INGREDIENT	A7V27PHC7A	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2
ZINGIBER MONTANUM FLOWERING TOP	INACTIVE INGREDIENT	P614KWN5QY	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58167-112	MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]	2	Legacy NDC, 2 package rows	20130513_56f84aae-ea47-4207-80da-3657bc1e0af2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1427005	camphor 4.5 % / menthol 37 % Topical Ointment	PSN	56f84aae-ea47-4207-80da-3657bc1e0af2	2
1427007	mata balm 4.5 % / 37 % Topical Ointment	PSN	56f84aae-ea47-4207-80da-3657bc1e0af2	2
1427007	camphor 0.045 MG/MG / menthol 0.37 MG/MG Topical Ointment [Mata Balm]	SBD	56f84aae-ea47-4207-80da-3657bc1e0af2	2
1427005	camphor 0.045 MG/MG / menthol 0.37 MG/MG Topical Ointment	SCD	56f84aae-ea47-4207-80da-3657bc1e0af2	2
1427005	camphor 4.5 % / menthol 37 % Topical Ointment	SY	56f84aae-ea47-4207-80da-3657bc1e0af2	2
1427007	Mata Balm (camphor 4.5 % / menthol 37 % ) Topical Balm	SY	56f84aae-ea47-4207-80da-3657bc1e0af2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58167-112-30	58167011230	1 in 1 BOX	Historical