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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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