FDA.reportPublic FDA data

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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
LEVOMENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
BZ1R15MTK7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235317Internal RxNorm lookup
1235322Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f34872c9-91b9-49db-8e41-5b54a069284aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-704-01Tact CoolJelly1 in 1 CARTONGEL17
49873-704-01Tact CoolJelly20 g in 1 TUBEGEL207

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]4
levomentholACTIVE INGREDIENTBZ1R15MTK7TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]4
diphenhydramineACTIVE MOIETY8GTS82S83MTACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]4
levomentholACTIVE MOIETYBZ1R15MTK7TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-704TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231202_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 118 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFId1ac686e-62f2-4177-8abc-8c7ca578de1a2024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Ince688967e-799a-4fc8-a19a-f0012b90e76b2024-11-15WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCa0d0e82b-03ff-4d43-9be0-0e414ee499702024-11-15WarningsExact identifier
application number: M017
DG health hydrocortisoneHYDROCORTISONEDolgencorp, LLC40710bae-32bb-47fd-b3dd-31d2c98ee70f2024-11-15WarningsExact identifier
application number: M017
Meijer Ultra Strength Pain Relieving Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEMeijer Distribution, Inc6319b019-8e17-4de1-b4e0-b402288a97d42024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving analgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc9953be94-5768-448f-83de-f5e53a2972cc2024-11-15WarningsExact identifier
application number: M017
careone anti itchHYDROCORTISONEAmerican Sales Company5f7b1435-ebee-4093-847a-79e8d66414042024-11-15WarningsExact identifier
application number: M017
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEALLIED TRADE LINK LLC26bc238d-3bda-0c29-e063-6394a90a35fb2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
application number: M017
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.26c7116f-c86d-8752-e063-6294a90ab73f2024-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235317diphenhydrAMINE HCl 2 % / levomenthol 1 % Topical GelPSNf34872c9-91b9-49db-8e41-5b54a069284a7
1235322Tact Cool Jelly 2 % / 1 % Topical GelPSNf34872c9-91b9-49db-8e41-5b54a069284a7
1235322diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]SBDf34872c9-91b9-49db-8e41-5b54a069284a7
1235317diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical GelSCDf34872c9-91b9-49db-8e41-5b54a069284a7
1235322Tact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical GelSYf34872c9-91b9-49db-8e41-5b54a069284a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-704-01498730704011 TUBE in 1 CARTON (49873-704-01) / 20 g in 1 TUBE1 tube1997-10-020000-00-00NoNoCurrent