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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact identifier
application number: M017
CVS Pain Relief Lavender ScentMENTHOL 4%CVS484b0833-9f8a-f155-e063-6294a90a18692026-01-13WarningsExact identifier
application number: M017
EARTHS CARE ANTI-ITCHCAMPHOR (NATURAL), MENTHOLDLC Laboratories, Inc.d1eabb5f-7086-4ff0-a398-3703c9ecd4412026-01-13WarningsExact identifier
application number: M017
HealthWise Cold Therapy Menthol Pain ReliefMENTHOLVeridian Healthcare25e3d9cd-6ba3-4e06-8853-324b9d6692482026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.1ac2ed54-194c-4de2-8e7f-6e74ca32aa402026-01-13WarningsExact identifier
application number: M017
Pain Release Joint and Arthritis CreamMENTHOLSaje Natural Business Inc.18b24d75-17f7-1a35-e063-6394a90a55e02026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.a32b0950-3467-4e37-988d-104836af59712026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.92eec6e7-0367-43c6-bd28-1762390a71142026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.481a493b-0620-46ac-8228-e9964b7eb24b2026-01-13WarningsExact identifier
application number: M017
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Eucalyptus Essential OilLIDOCAINE HCLChattem, Inc.03e247b4-a2e2-4354-a018-880f1bc987fd2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsExact identifier
application number: M017
Capzasin HP Arthritis Pain ReliefCAPSAICINChattem, Inc.345c9159-0efe-436b-9068-3b717678936b2026-01-13WarningsExact identifier
application number: M017
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
application number: M017
Aspercreme Pain RelievingTROLAMINE SALICYLATEChattem, Inc.97dd587b-ecc3-4b4b-a116-6355d3c6ea6d2026-01-13WarningsExact identifier
application number: M017
Dr Wellskin Numbing Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD482f25cc-dee3-c3b6-e063-6294a90a86742026-01-12WarningsExact 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