FDA.reportPublic FDA data

TACT

Product NDC
49873-705
11-digit product format
498730705
Labeler code
49873
Product ID
49873-705_0bb93753-9288-eb0b-e063-6394a90a950b
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride, menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Sato Pharmaceutical Inc., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-09-09
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
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
1245398Internal RxNorm lookup
1245403Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6e2ee24-69de-4dfd-9081-b9537b7a7badAvailable 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-705-01TACT20 g in 1 TUBECREAM204
49873-705-01TACT1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ETACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2VTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RTACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-705TACT (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) CREAM [SATO PHARMACEUTICAL INC., LTD.]4Current NDC, Legacy NDC, 2 package rows20231205_b6e2ee24-69de-4dfd-9081-b9537b7a7bad.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 81 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOEHYDROCORTISONEClick Industries LLC328c389c-7e05-4892-a9b3-b6a753f4935a2025-08-25WarningsExact identifier
application number: M017
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLNatures Formulae Health Products Ltd.3ce29160-3964-e435-e063-6394a90abb382025-08-21WarningsExact identifier
application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
application number: M017
Camphor 4% Plus Menthol 10%CAMPHOR 4% PLUS MENTHOL 10%PureTek Corporation3cab26e4-e377-f26a-e063-6394a90a17af2025-08-20WarningsExact identifier
application number: M017
Capsaicin 0.035% CreamCAPSAICIN 0.035% CREAMPuretekcorp3cbc73b6-8c58-8f23-e063-6394a90a71a32025-08-20WarningsExact identifier
application number: M017
Game OnMENTHOL, METHYL SALICYLATENatural Essentials, Inc.3cd20f1f-033f-f698-e063-6294a90a89eb2025-08-20WarningsExact identifier
application number: M017
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245398diphenhydrAMINE HCl 2 % / levomenthol 1 % Topical CreamPSNb6e2ee24-69de-4dfd-9081-b9537b7a7bad4
1245403Tact 2 % / 1 % Topical CreamPSNb6e2ee24-69de-4dfd-9081-b9537b7a7bad4
1245403diphenhydramine hydrochloride 20 MG/ML / levomenthol 10 MG/ML Topical Cream [Tact]SBDb6e2ee24-69de-4dfd-9081-b9537b7a7bad4
1245398diphenhydramine hydrochloride 20 MG/ML / levomenthol 10 MG/ML Topical CreamSCDb6e2ee24-69de-4dfd-9081-b9537b7a7bad4
1245403Tact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical CreamSYb6e2ee24-69de-4dfd-9081-b9537b7a7bad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-705-01498730705011 TUBE in 1 CARTON (49873-705-01) / 20 g in 1 TUBE1 tube1997-09-090000-00-00NoNoCurrent