FDA.reportPublic FDA data

Solstice Pain Relieving

Product NDC
55614-210
11-digit product format
556140210
Labeler code
55614
Product ID
55614-210_43460d86-e2ec-0e78-e063-6294a90ae47d
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
MADISON ONE ACME INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-26
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
3.1; 6; 10 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Solstice Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.1 g/100g
MENTHOL6 g/100g
METHYL SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1793147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ef90782-8201-47d1-b57f-f032d4c9b06aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-210-02Solstice Pain Relieving2 in 1 POUCHPATCH25
55614-210-02Solstice Pain Relieving9 g in 1 PATCHPATCH95
55614-210-20Solstice Pain Relieving20 in 1 BOXPATCH205
55614-210-20Solstice Pain Relieving9 g in 1 PATCHPATCH95
55614-210-60Solstice Pain Relieving9 g in 1 PATCHPATCH95
55614-210-60Solstice Pain Relieving60 in 1 BOXPATCH605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-210SOLSTICE PAIN RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [MADISON ONE ACME INC]4Current NDC, Legacy NDC, 6 package rows20241127_5ef90782-8201-47d1-b57f-f032d4c9b06a.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 114 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicaine Sting and BiteBENZOCAINEJames Alexander Corporation753e6cbe-31e0-4017-93d0-8b4bf5972f372024-12-09WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.df239c4d-af6a-41ca-baed-d0788782ce9f2024-12-08WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.8b30f623-6077-4f2e-8fa4-ce4a298953b52024-12-08WarningsExact identifier
application number: M017
QC Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLChain Drug Marketing Associationb5e41e3a-81df-3a63-e053-2a95a90a58392024-12-08WarningsExact identifier
application number: M017
QC Lidocaine Maximum StrengthLIDOCAINE HCLChain Drug Marketing Associationb5e1b1ab-8a95-2d2d-e053-2995a90aea532024-12-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAlexso, Inc433da27d-04fb-481a-bbb0-874bb72c806a2024-12-06WarningsExact identifier
application number: M017
POMG PAIN RELIEF BODYLIDOCAINEPOMG LLC28d7ac46-b27f-43bb-e063-6294a90a93ed2024-12-06WarningsExact identifier
application number: M017
Capsaicin 0.1 PercentCAPSAICINAlexso, Inc0090ca38-6433-45c4-9453-edf2788c14c62024-12-06WarningsExact identifier
application number: M017
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN5ef90782-8201-47d1-b57f-f032d4c9b06a5
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD5ef90782-8201-47d1-b57f-f032d4c9b06a5
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY5ef90782-8201-47d1-b57f-f032d4c9b06a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55614-210-02556140210022 PATCH in 1 POUCH (55614-210-02) / 9 g in 1 PATCH2 patch2019-07-260000-00-00NoNoCurrent
55614-210-205561402102020 PATCH in 1 BOX (55614-210-20) / 9 g in 1 PATCH20 patch2019-07-260000-00-00NoNoCurrent
55614-210-605561402106060 PATCH in 1 BOX (55614-210-60) / 9 g in 1 PATCH60 patch2019-07-260000-00-00NoNoCurrent