TheraPlus

Product NDC: 55621-004
11-digit product format: 556210004
Labeler code: 55621
Product ID: 55621-004_08831525-5717-3c3d-e063-6394a90a5aed
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-03-01
Substance: MENTHOL; MENTHYL SALICYLATE, (+/-)-
Active strength: 10; 15 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: TheraPlus
Brand name suffix: Plus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	10 g/100g
MENTHYL SALICYLATE, (+/-)-	15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
43XOA705ZD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311499	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d4119f84-eb60-4134-b58e-de13d9601199	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55621-004-01	TheraPlus Plus	28 g in 1 TUBE	OINTMENT	28		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
MENTHYL SALICYLATE, (+/-)-	ACTIVE INGREDIENT	43XOA705ZD	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55621-004	THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	6	Current NDC, Legacy NDC, 1 package rows	20231025_d4119f84-eb60-4134-b58e-de13d9601199.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 54 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Burn Cream	FIRST AID BURN CREAM	ProStat First Aid LLC	0037a1a4-d747-2567-e063-6394a90a721c	2025-12-15	Warnings	Exact identifier application number: M017
PS-3885 Burn Ease, 3.5g	PS-3885 BURN EASE, 3.5G	ProStat First Aid LLC	004c6deb-2844-a0d0-e063-6394a90ae5e4	2025-12-15	Warnings	Exact identifier application number: M017
2677 First Aid Burn Cream	2677 FIRST AID BURN CREAM	ProStat First Aid LLC	ff5bb628-8ef7-4540-e053-6394a90a55ed	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71b98b4-22d0-0124-e053-6394a90ae4cf	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71eb4f5-2280-5867-e053-6394a90aac57	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8e6842-c889-d5d3-e063-6394a90af880	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8c59fb-3622-2bb7-e063-6294a90adc6e	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	Front Line Safety	0e34cb09-d8c6-f8c0-e063-6294a90a0be0	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f52021f-af8a-5b95-e063-6294a90a2c2a	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	0e25c936-e40a-e23c-e063-6294a90ac0e4	2025-12-15	Warnings	Exact identifier application number: M017
Sting Relief Wipes	STING RELIEF WIPES	ProStat First Aid LLC	0e20252a-5ecb-2526-e063-6294a90a8cde	2025-12-15	Warnings	Exact identifier application number: M017
First Aid Burn Cream	FIRST AID BURN CREAM	Front Line Safety	0f4ce2c2-f306-d95f-e063-6394a90ae7b3	2025-12-15	Warnings	Exact identifier application number: M017
Magsoothium Body	MENTHOL, CAPSAICIN	Ubu/Elements, Inc.	f604d30c-b17c-ec01-e053-2a95a90aa304	2025-12-15	Warnings	Exact identifier application number: M017
Salonpas pain relieving JET	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	dd1ea3bf-891a-402e-8f43-14302bc9c3e5	2025-12-15	Warnings	Exact identifier application number: M017
Herbal Tendon Bone Relief	CAMPHOR MINT	Guchutang Biotechnology (Longyan) Co., Ltd.	45cf4040-9751-d24b-e063-6294a90aff27	2025-12-13	Warnings	Exact identifier application number: M017
ElixirLidoFast	LIDOCAINE 5% CREAM	ELIXIR HEALTHCARE USA, LLC.	45de5a3d-06c2-aa02-e063-6294a90a63d3	2025-12-13	Warnings	Exact identifier application number: M017
MEDI FIRST PLUS	HYDROCORTISONE ACETATE	Orazen Inc	5781124a-60f4-4a64-80b7-ce5f28d495b5	2025-12-12	Warnings	Exact identifier application number: M017
MEDI-FIRST	HYDROCORTISONE ACETATE	Orazen Inc	aeffd85c-58a7-4d64-bf94-977b6fbbe713	2025-12-12	Warnings	Exact identifier application number: M017
Joint and Muscle Relief	MENTHOL	Smart Cookie Solutions Inc.	45c24d56-4dc9-2884-e063-6294a90a52cc	2025-12-12	Warnings	Exact identifier application number: M017
Popstar	DELAY SPRAY	Pineapple Brands LLC	293b2da9-1261-0358-e063-6394a90aa08c	2025-12-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43XOA705ZD	MENTHYL SALICYLATE, (+/-)-	89-46-3	MENTHYL SALICYLATE, (+/-)-

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311499	menthol 10 % / methyl salicylate 15 % Topical Ointment	PSN	d4119f84-eb60-4134-b58e-de13d9601199	6
311499	menthol 0.1 MG/MG / methyl salicylate 0.15 MG/MG Topical Ointment	SCD	d4119f84-eb60-4134-b58e-de13d9601199	6
311499	menthol 10 % / methyl salicylate 15 % Topical Ointment	SY	d4119f84-eb60-4134-b58e-de13d9601199	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55621-004-01	55621000401	28 g in 1 TUBE (55621-004-01)	28 g	2013-03-01	0000-00-00	No	No	Current