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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017
The Best Numbing CreamTBNCThe Best Numbing Cream LLC4ca3923b-f586-0aaf-e063-6294a90a16c12026-03-31WarningsExact identifier
application number: M017
ChapStick Classic MedicatedEXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALMSuave Brands Co., LLC42798a6c-2d7e-80f6-e063-6294a90a105f2026-03-31WarningsExact identifier
application number: M017
Roll-On Pain Relief LiquidLIDOCAINE HCLHyVee Inc4da6f6fb-b182-360f-e063-6294a90abdf32026-03-31WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4e54aecb-190f-3866-e063-6294a90a810a2026-03-31WarningsExact identifier
application number: M017
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
application number: M017
ZENOL COOLMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4e5c45f4-88ce-3a13-e063-6394a90a2a092026-03-31WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited091451fb-e30a-0012-e063-6394a90a3ba82026-03-31WarningsExact identifier
application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and MintMENTHOLChattem, Inc.b16ba9c2-23bf-4fdf-b44b-7abb9fec19112026-03-31WarningsExact identifier
application number: M017
DR.PABU NUMBINGLIDOCAINE 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4e3a3c6c-4821-76ea-e063-6294a90a8f962026-03-30WarningsExact identifier
application number: M017
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsExact identifier
application number: M017
CVS Muscle Balm and Roll-OnCAMPHOR, MENTHOLCVS Pharmacy4e40025a-070a-508e-e063-6394a90af5d72026-03-30WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLCc3eec066-38e8-4617-b34d-2f72ffb7a3242026-03-30WarningsExact identifier
application number: M017
Softlips Naturals Medicated Matcha HoneyCAMPHOR, MENTHOLThe Mentholatum Company4e03a721-73f3-b2f2-e063-6394a90a44e62026-03-27WarningsExact 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