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 130 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact 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