Tact Cool

Product NDC: 49873-704
11-digit product format: 498730704
Labeler code: 49873
Product ID: 49873-704_0b7d17ee-250b-f137-e063-6394a90a3f14
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride, levomenthol
Dosage form: GEL
Route: TOPICAL
Labeler: Sato Pharmaceutical Co., Ltd.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1997-10-02
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; LEVOMENTHOL
Active strength: 2; 1 g/100g; g/100g
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Tact Cool
Brand name suffix: Jelly
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	2 g/100g
LEVOMENTHOL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
BZ1R15MTK7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1235317	Internal RxNorm lookup
1235322	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
f34872c9-91b9-49db-8e41-5b54a069284a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-704-01	Tact CoolJelly	1 in 1 CARTON	GEL	1		7
49873-704-01	Tact CoolJelly	20 g in 1 TUBE	GEL	20		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]	4
levomenthol	ACTIVE INGREDIENT	BZ1R15MTK7	TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]	4
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]	4
levomenthol	ACTIVE MOIETY	BZ1R15MTK7	TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-704	TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]	7	Current NDC, Legacy NDC, 2 package rows	20231202_f34872c9-91b9-49db-8e41-5b54a069284a.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 150 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Exact identifier application number: M017
Red hot	CAPSAICIN	The Hygenic Company, LLC	d100092c-e10b-2063-e053-2995a90aedb2	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	c8d4ae28-efc4-6a00-e053-2a95a90a40bf	2023-10-25	Warnings	Exact identifier application number: M017
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	3336cc35-e773-4705-84b5-61040604beef	2023-10-25	Warnings	Exact identifier application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant	BENZOCAINE, WHITE PETROLATUM	Carma Laboratories, Inc.	bbf0abcd-b7d6-b5e4-e053-2995a90a5240	2023-10-25	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bbee66b9-39ff-4e7e-e053-2995a90a43be	2023-10-25	Warnings	Exact identifier application number: M017
XtraCare Ice Cold Topical Analgesic Gel	MENTHOL	Rejoice International	d38f3099-d940-44d8-aa7f-404157c5e0e3	2023-10-24	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
BZ1R15MTK7	LEVOMENTHOL	2216-51-5	LEVOMENTHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1235317	diphenhydrAMINE HCl 2 % / levomenthol 1 % Topical Gel	PSN	f34872c9-91b9-49db-8e41-5b54a069284a	7
1235322	Tact Cool Jelly 2 % / 1 % Topical Gel	PSN	f34872c9-91b9-49db-8e41-5b54a069284a	7
1235322	diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]	SBD	f34872c9-91b9-49db-8e41-5b54a069284a	7
1235317	diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel	SCD	f34872c9-91b9-49db-8e41-5b54a069284a	7
1235322	Tact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical Gel	SY	f34872c9-91b9-49db-8e41-5b54a069284a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49873-704-01	49873070401	1 TUBE in 1 CARTON (49873-704-01) / 20 g in 1 TUBE	1 tube	1997-10-02	0000-00-00	No	No	Current