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
2027-12-31
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
Salonpas LIDOCAINE PLUS
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LKG8494WBHInternal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1943537Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea5b4a7f-d47d-4dbd-9288-c01329e387e5Available on FDA.report

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

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 128 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
application number: M017
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.fbbbcc67-b46d-d41a-e053-6294a90aa55d2024-08-08WarningsExact identifier
application number: M017
Cheezheng Pain Relief CreamMENTHOLTibet Cheezheng Tibetan Medicine Co. Ltd37279a3f-9207-4e4c-90d6-52735044f1042024-08-07WarningsExact identifier
application number: M017
CVS Health Hydrocortisone Anti ItchHYDROCORTISONECVS Health546a1b8a-8254-432a-85c4-38ebee5ad5682024-08-07WarningsExact identifier
application number: M017
SANTO REMEDIO Alivio Pain Relieving Lavender ScentLIDOCAINE HYDROCHLORIDE, MENTHOLSANTO REMEDIO LLCab53c7f2-a768-4f36-89d6-e128a1a940c22024-08-05WarningsExact identifier
application number: M017
CVS Health Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTCVS Healthee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf32024-08-02WarningsExact identifier
application number: M017
Anti-Itch Vulva Cream 1 Hydrocortisone AcetateHYDROCORTISONE ACETATEThe Honey Pot Company LLC6f32b536-6ebf-49a8-abb6-2a1daae2f6d72024-08-01WarningsExact identifier
application number: M017
Anti Itch Soothing 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC8bfeea34-25d5-4721-a17f-d9f1d0084cc32024-08-01WarningsExact identifier
application number: M017
AVON footworks Arthritis Achy Foot and MuscleMETHYL SALICYLATEThe Avon Company1f440f60-cfc4-511e-e063-6294a90a87db2024-08-01WarningsExact identifier
application number: M017
AVON footworks Maximum Strength Cracked HeelBENZALKONIUM CHLORIDE, LIDOCAINEThe Avon Company1f45752e-4a55-431e-e063-6294a90aa57a2024-08-01WarningsExact identifier
application number: M017
ReliefMENTHOLLa Mend, Inc.1f92de3a-7180-5884-e063-6294a90aebf52024-08-01WarningsExact identifier
application number: M017
Meijer Medicated Foot PowderMENTHOLMeijer Distribution07ec6c20-73c4-e5e4-e063-6294a90a7e552024-07-29WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.e05ec3b7-e9ab-4eaa-8518-86304336697c2024-07-29WarningsExact identifier
application number: M017
Walgreens Roll-OnCAPSAISIN 0.1%Walgreens Co1e65bf31-15c7-5e6a-e063-6394a90ac9562024-07-29WarningsExact identifier
application number: M017
CamphotrexCAMPHOR, MENTHOLPureTek Corporation3b6c6eef-e92d-497d-afe8-82356637c2b82024-07-26WarningsExact identifier
application number: M017
CamphotrolCAMPHOR, MENTHOLPureTek Corporationccac9f37-a374-4765-e053-2a95a90ad2f72024-07-26WarningsExact identifier
application number: M017
Real Time Pain Relief FootMENTHOLReal Time Products Inc.29c8e06d-9b29-44f9-ac21-9160d06475cb2024-07-24WarningsExact identifier
application number: M017
Capsaicin 0.075 PercentCAPSAICINAlexso, Inc33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd2024-07-22WarningsExact identifier
application number: M017
TIDL Pain Relief CRYO Therapy Limited EditionPAIN RELIEF CRYO THERAPY LIMITED EDITIONShenzhen Sam Technology Co., Ltd.1d966b67-fd9c-eab6-e063-6294a90aa75e2024-07-19WarningsExact identifier
application number: M017

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