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 firm2026-10-21

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 102 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLCd4276749-eeff-28f7-e053-2a95a90a593d2025-01-31WarningsExact identifier
application number: M017
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
application number: M017
Maximum Strength Blue Emu Pain Relief Blu EmuTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC5e02b820-e53a-42cb-abdb-2925617c29ca2025-01-31WarningsExact identifier
application number: M017
Sunset Novelties HerquakeNUMBING LUBRICANTSUNSET INTIMATES GROUP INC2ceeca3e-9197-9166-e063-6394a90ae9082025-01-30WarningsExact identifier
application number: M017
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact 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