FDA.reportPublic FDA data

Tact Cream

Manufacturer
Sato Pharmaceutical Inc., Ltd.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:17

Label at a glance#

ProductTACT
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients  
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%

OTC - PURPOSE SECTION

Purpose   
Diphenhydramine Hydrochloride    External analgesic
l-Menthol    External analgesic

INDICATIONS & USAGE SECTION

Uses
temporarily relieves pain and itching associated with
■ minor skin irritations    ■ insect bites    ■ minor cuts    ■ scrapes
■ rashes due to poison ivy    ■ sunburn        ■ minor burns

WARNINGS SECTION

Warnings
For rectal use only

OTC - WHEN USING SECTION

When using this product

■ avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ condition worsens ■ symptoms persist for more than 7 days.

■ symptoms clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ adults and children 2 years and over:  Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years:  Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients  butylparaben, carboxyvinyl polymer, cetyl alcohol, diethanolamine, edetate disodium, light mineral oil, PEG-40 stearate, propylene glycol, propylparaben, purified water, sorbitan monostearate, white petrolatum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


tactcreamcart.jpg cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245398diphenhydrAMINE HCl 2 % / levomenthol 1 % Topical CreamPSN4
1245403Tact 2 % / 1 % Topical CreamPSN4
1245403diphenhydramine hydrochloride 20 MG/ML / levomenthol 10 MG/ML Topical Cream [Tact]SBD4
1245398diphenhydramine hydrochloride 20 MG/ML / levomenthol 10 MG/ML Topical CreamSCD4
1245403Tact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK71
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
MENTHOLACTIVE MOIETYL7T10EIP3A1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2V1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q71
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-70549873-705-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHANOLAMINEAZE05TDV2VIACT
EDETATE SODIUMMP1J8420LUIACT
LIGHT MINERAL OILN6K5787QVPIACT
PEG-40 STEARATEECU18C66Q7IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
PETROLATUM4T6H12BN9UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
BUTYLPARABEN3QPI1U3FV8IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DIETHANOLAMINEDIETHANOLAMINEAZE05TDV2VCREAM / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIETHANOLAMINEDIETHANOLAMINEAZE05TDV2VCREAM / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
ndc (package): 49873-705-01
ndc (product): 49873-705
ndc11 (package): 49873070501
spl id: 0bb93753-9288-eb0b-e063-6394a90a950b
spl set id: b6e2ee24-69de-4dfd-9081-b9537b7a7bad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.