FDA.reportPublic FDA data

Salonpas LIDOCAINE PLUS

Product NDC
55328-902
11-digit product format
553280902
Labeler code
55328
Product ID
55328-902_24d33c2c-0a51-4775-a5a0-0fa22afa5482
Type
HUMAN OTC DRUG
Nonproprietary name
Benzyl alcohol, Lidocaine hydrochloride
Dosage form
CREAM
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Hisamitsu America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-23
Substance
BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE
Active strength
10; 4 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Salonpas LIDOCAINE PLUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZYL ALCOHOL10 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLKG8494WBH, V13007Z41A
Rxcui1926513

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55328-902-03Salonpas LIDOCAINE PLUS1 in 1 BOXCREAM15
55328-902-03Salonpas LIDOCAINE PLUS85 g in 1 TUBECREAM855

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55328-902-03GM - Gram55328-90264838a4e-ebad-4a03-a965-2a17e0d012ee12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55328-902SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) CREAM [HISAMITSU AMERICA, INC.]5Current NDC, Legacy NDC, 2 package rows20241205_364924d3-fac3-4f4e-9b40-decd4ec48245.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamPSN364924d3-fac3-4f4e-9b40-decd4ec482455
1926513benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD364924d3-fac3-4f4e-9b40-decd4ec482455
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamSY364924d3-fac3-4f4e-9b40-decd4ec482455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55328-902-03553280902031 TUBE in 1 BOX (55328-902-03) / 85 g in 1 TUBE1 tube2017-06-230000-00-00NoNoCurrent