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 firm2026-10-20

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 88 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact 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