FDA.reportPublic FDA data

Soothing Nerve Therapy

Product NDC
42346-550
11-digit product format
423460550
Labeler code
42346
Product ID
42346-550_41a30e52-be92-76f6-e063-6294a90a0295
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Wise Consumer Products
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-16
Substance
MENTHOL
Active strength
1.3 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42346-55042346-550-85DDiscontinued by firm2026-10-23

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
Soothing Nerve Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2045268Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
40829d6b-5005-7ec9-e063-6294a90a970eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42346-550-85Soothing Nerve Therapy85 g in 1 TUBELOTION852
42346-550-86Soothing Nerve Therapy85 g in 1 TUBELOTION852
42346-550-86Soothing Nerve Therapy1 in 1 CARTONLOTION12
42346-550-87Soothing Nerve Therapy85 g in 1 TUBELOTION852
42346-550-87Soothing Nerve Therapy2 in 1 CARTONLOTION22
42346-550-86Frankincense and Myrrh Nerve Combo Pack85 g in 1 TUBELOTION85 g1.3 g in 100g1
42346-550-86Frankincense and Myrrh Nerve Combo Pack1 in 1 CARTONLOTION1.3 g in 100g1

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 131 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAsclemed USA, Inc.97d506bd-3215-4e2e-9914-af1c174dd4ab2024-06-20WarningsExact identifier
application number: M017
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain RelieverCAPSAICINWHY ENTERPRISES LLCe32acb5f-5bc3-4228-b037-6315d080f5562024-06-17WarningsExact identifier
application number: M017
PUREGEN LABS Pain Relief 4 LidocaineLIDOCAINEAdvanced Rx LLC9dff40d8-8d7e-4629-bea5-987f5e68477d2024-06-11WarningsExact identifier
application number: M017
SMOOTH GATOR Head-Ezz AnalgesicMENTHOLSmooth Gator LLC02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd2024-06-10WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.1c834ba0-86b6-8e61-e063-6394a90a192d2024-06-04WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare19fe7c3b-58e2-6c16-e063-6394a90a612a2024-06-03WarningsExact identifier
application number: M017
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
application number: M017
Methyl Salicylate 25 PercentMETHYL SALICYLATEAlexso, Incd8b8b0ba-69e9-4965-bf9b-6db21db69b342024-05-23WarningsExact identifier
application number: M017
Meijer Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMeijer Distribution07ecc6a7-bbe3-35cf-e063-6394a90a21802024-05-22WarningsExact identifier
application number: M017
TheraCare Hydrocortisone CreamHYDROCORTISONEVeridian Healthcare01cb7b47-2c3c-707d-e063-6294a90a5d972024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2045268menthol 1.3 % Topical LotionPSN40829d6b-5005-7ec9-e063-6294a90a970e2
2045268menthol 13 MG/ML Topical LotionSCD40829d6b-5005-7ec9-e063-6294a90a970e2
2045268menthol 1.3 % Topical LotionSY40829d6b-5005-7ec9-e063-6294a90a970e2
2045268menthol 1.3 % Topical LotionPSN471d815c-1c34-e0f8-e063-6294a90aca781
2675594menthol 2 % Topical OilPSN471d815c-1c34-e0f8-e063-6294a90aca781
2045268menthol 13 MG/ML Topical LotionSCD471d815c-1c34-e0f8-e063-6294a90aca781
2675594menthol 20 MG/ML Topical OilSCD471d815c-1c34-e0f8-e063-6294a90aca781
2045268menthol 1.3 % Topical LotionSY471d815c-1c34-e0f8-e063-6294a90aca781
2675594menthol 2 % Topical OilSY471d815c-1c34-e0f8-e063-6294a90aca781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42346-550-854234605508585 g in 1 TUBE85 gHistorical
42346-550-86423460550861 TUBE in 1 CARTON (42346-550-86) / 85 g in 1 TUBE1 tube2025-12-17NoNoCurrent
42346-550-87423460550872 TUBE in 1 CARTON (42346-550-87) / 85 g in 1 TUBE2 tube2025-11-14NoNoCurrent