FDA.reportPublic FDA data

SynoFlex Patch

Product NDC
70512-015
11-digit product format
705120015
Labeler code
70512
Product ID
70512-015_4572a05d-f41c-883d-e063-6394a90ac5d2
Type
HUMAN OTC DRUG
Nonproprietary name
SynoFlex Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Sola Pharmaceuticals
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-28
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
40; 50 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
SynoFlex Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/g
MENTHOL50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2600301Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de2042c4-6c5e-7365-e053-2a95a90ada2aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-015-15SynoFlex Patch3 in 1 BOXPATCH35
70512-015-15SynoFlex Patch5 g in 1 POUCHPATCH55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-015-15EA - Each70512-015c2f6ca05-6227-451b-9d84-c807ed7ad05e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-015SYNOFLEX PATCH PATCH [SOLA PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20240522_de2042c4-6c5e-7365-e053-2a95a90ada2a.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 139 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XRay Pain ReliefMENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATEGenomma Lab USA5244ddee-fd9e-4df3-8fb3-b16aa321a3162023-12-27WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Pharma Nobis, LLCe42fbe63-b01c-4f85-e053-2a95a90a51432023-12-26WarningsExact identifier
application number: M017
Equate CalasprayPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Walmart Inc027ed5ab-05ec-569f-e063-6394a90abbc32023-12-26WarningsExact identifier
application number: M017
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
application number: M017
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
application number: M017
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Itch Relief GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesicLIDOCAINE HYDROCHLORIDEWal-Mart Stores, Inc.bf954949-a7b7-44ba-8565-f1d5c0a6c0d12023-12-21WarningsExact identifier
application number: M017
Bactine Max BandageLIDOCAINEWellSpring Pharmaceutical Corporation465dc46e-6435-4569-9516-f648d0fe0f092023-12-21WarningsExact identifier
application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2600301lidocaine HCl 4 % / menthol 5 % Medicated PatchPSNde2042c4-6c5e-7365-e053-2a95a90ada2a5
2600301lidocaine hydrochloride 0.04 MG/MG / menthol 0.05 MG/MG Medicated PatchSCDde2042c4-6c5e-7365-e053-2a95a90ada2a5
2600301lidocaine HCl 4 % / menthol 5 % Medicated PatchSYde2042c4-6c5e-7365-e053-2a95a90ada2a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70512-015-15705120015153 POUCH in 1 BOX (70512-015-15) / 5 g in 1 POUCH3 pouch2022-04-280000-00-00NoNoCurrent