FDA.reportPublic FDA data

Salonpas LIDOCAINE PLUS

Product NDC
55328-901
11-digit product format
553280901
Labeler code
55328
Product ID
55328-901_cd6de492-966e-4127-aca7-dc865243b42a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzyl alcohol, Lidocaine hydrochloride
Dosage form
LIQUID
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Hisamitsu America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-01
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
Rxcui1943537

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55328-901-03Salonpas LIDOCAINE PLUS80 g in 1 TUBELIQUID804
55328-901-03Salonpas LIDOCAINE PLUS1 in 1 BOXLIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55328-901-03ML - Milliliter55328-90145b99e7c-9b83-422c-9b06-a90589df4a2412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55328-901SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [HISAMITSU AMERICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241205_ea5b4a7f-d47d-4dbd-9288-c01329e387e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionPSNea5b4a7f-d47d-4dbd-9288-c01329e387e54
1943537benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SolutionSCDea5b4a7f-d47d-4dbd-9288-c01329e387e54
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionSYea5b4a7f-d47d-4dbd-9288-c01329e387e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55328-901-03553280901031 TUBE in 1 BOX (55328-901-03) / 80 g in 1 TUBE1 tube2017-09-010000-00-00NoNoCurrent