Home NDC 49873-704 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 Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g LEVOMENTHOL 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup BZ1R15MTK7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1235317 Internal RxNorm lookup 1235322 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49873-704-01 Tact CoolJelly 1 in 1 CARTON GEL 1 7 49873-704-01 Tact CoolJelly 20 g in 1 TUBE GEL 20 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.] 4 levomenthol ACTIVE INGREDIENT BZ1R15MTK7 TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.] 4 diphenhydramine ACTIVE MOIETY 8GTS82S83M TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.] 4 levomenthol ACTIVE MOIETY BZ1R15MTK7 TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49873-704 TACT COOL JELLY (DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL) GEL [SATO PHARMACEUTICAL CO., LTD.] 7 Current NDC, Legacy NDC, 2 package rows 20231202_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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49873-704-01 49873070401 1 TUBE in 1 CARTON (49873-704-01) / 20 g in 1 TUBE 1 tube 1997-10-02 0000-00-00 No No Current