MOLYHEN

Product NDC: 50629-1010
11-digit product format: 506291010
Labeler code: 50629
Product ID: 50629-1010_c76e93dd-0da7-41eb-9319-d44ad0c1bb92
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: SEWHA P&C INC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-06-29
Marketing end: 0000-00-00
Substance: MENTHOL; .ALPHA.-TOCOPHEROL ACETATE, D-; SWERTIA JAPONICA; PYRIDOXINE HYDROCHLORIDE
Active strength: 4 mL/200mL; mL/200mL; mL/200mL; mL/200mL
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	50629-1010		I	Inactivated by FDA		2026-10-20
excluded package	package	50629-1010	50629-1010-2	I	Inactivated by FDA		2026-10-20

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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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	50629-1010-2	`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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
22bca8fc-c2b1-897d-b515-117a7522ccae	Product name	3	20150731
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50629-1010-2	2019-11-13	C162847	48780-1	97449f38-c3b6-f6ea-e053-dbdaa90aa703	MOLYHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50629-1010-1	MOLYHEN	200 mL in 1 BOTTLE	LIQUID	200		2
50629-1010-2	MOLYHEN	1 in 1 BOX	LIQUID	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.ALPHA.-TOCOPHEROL ACETATE, D-	ACTIVE INGREDIENT	A7E6112E4N	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
SWERTIA JAPONICA	ACTIVE INGREDIENT	01X0P6GX6C	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
.ALPHA.-TOCOPHEROL ACETATE, D-	ACTIVE MOIETY	A7E6112E4N	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
SWERTIA JAPONICA	ACTIVE MOIETY	01X0P6GX6C	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
.BETA.-THUJAPLICIN	INACTIVE INGREDIENT	U5335D6EBI	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ANGELICA DAHURICA ROOT	INACTIVE INGREDIENT	1V63N2S972	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ANGELICA GIGAS ROOT	INACTIVE INGREDIENT	32766B2FHX	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
CAMELLIA JAPONICA SEED OIL	INACTIVE INGREDIENT	U37N0S910T	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
CENTAUREA CYANUS FLOWER	INACTIVE INGREDIENT	QZ239038YC	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
CYSTEINE HYDROCHLORIDE	INACTIVE INGREDIENT	ZT934N0X4W	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ECLIPTA PROSTRATA LEAF	INACTIVE INGREDIENT	H86R96580E	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
HYDROGENATED SOYBEAN LECITHIN	INACTIVE INGREDIENT	H1109Z9J4N	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
INONOTUS OBLIQUUS FRUITING BODY	INACTIVE INGREDIENT	MRO1FS760M	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ISATIS TINCTORIA ROOT	INACTIVE INGREDIENT	8S10GFI6DX	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
JUJUBE FRUIT	INACTIVE INGREDIENT	G55HNL2C70	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
LAWSONIA INERMIS LEAF	INACTIVE INGREDIENT	E5818YZ355	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MORUS ALBA LEAF	INACTIVE INGREDIENT	M8YIA49Q2P	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
MORUS ALBA ROOT	INACTIVE INGREDIENT	CST1G9BZGD	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
O-CYMEN-5-OL	INACTIVE INGREDIENT	H41B6Q1I9L	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
PLATYCLADUS ORIENTALIS LEAF	INACTIVE INGREDIENT	32E5V7G32B	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
POLYOXYL 60 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	02NG325BQG	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
QUININE	INACTIVE INGREDIENT	A7V27PHC7A	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
REISHI	INACTIVE INGREDIENT	TKD8LH0X2Z	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
SAGE	INACTIVE INGREDIENT	065C5D077J	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
SALVIA MILTIORRHIZA ROOT	INACTIVE INGREDIENT	1693AM5SBN	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
SODIUM COCOYL GLUTAMATE	INACTIVE INGREDIENT	BMT4RCZ3HG	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ULMUS DAVIDIANA ROOT	INACTIVE INGREDIENT	URQ79U8261	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
VITEX TRIFOLIA FRUIT	INACTIVE INGREDIENT	Q04E1F5351	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2
ZINGIBER CASSUMUNAR ROOT	INACTIVE INGREDIENT	3NG517NPD8	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50629-1010	MOLYHEN (MENTHOL) LIQUID [SEWHA P&C INC]	2	Legacy NDC, 2 package rows	20120521_a532325f-050f-40dd-b047-fd28b0b2911d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A7E6112E4N	.ALPHA.-TOCOPHEROL ACETATE, D-	58-95-7	.ALPHA.-TOCOPHEROL ACETATE, D-
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50629-1010-1	50629101001	200 mL in 1 BOTTLE	200 ml	Historical
50629-1010-2	50629101002	1 in 1 BOX		Historical