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 68 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
application number: M017
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
application number: M017
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
application number: M017
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
application number: M017
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINE AND MENTHOLBullet point LLC42c70681-494b-47c9-e063-6394a90a80be2025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLCba6c7e97-d740-484b-8711-55fa7ab157842025-11-04WarningsExact identifier
application number: M017
China-GelMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, Inc.d7c5cb17-f7a2-7f57-e053-2995a90a40f72025-11-04WarningsExact identifier
application number: M017
Aulief Topical Pain RelieverMENTHOL AND CAMOHORChina-Gel, LLC8647dcc3-1dbc-1093-e053-2991aa0a1ab92025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLC254abae9-ef1b-5a90-e054-00144ff88e882025-11-04WarningsExact identifier
application number: M017
Pain Relief Gel-TubeMENTHOLBullet point LLC42c93789-9758-54b7-e063-6394a90ac3982025-11-04WarningsExact identifier
application number: M017
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
application number: M017
CORE RELIEFCAMPHOR, MENTHOLCopper Joint, LLC42d17270-f58d-9d69-e063-6294a90a40782025-11-04WarningsExact identifier
application number: M017
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
application number: M017
Goodsense Extra Strength Cold and Hot MedicatedMENTHOLGeiss, Destin and Dunn, Inc.7585d111-775f-4fb6-a485-28cd99d888522025-10-31WarningsExact 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