FDA.reportPublic FDA data

NeuroCool Patches

Product NDC
85622-500
11-digit product format
856220500
Labeler code
85622
Product ID
85622-500_410c317c-abc4-f5da-e063-6394a90ab916
Type
HUMAN OTC DRUG
Nonproprietary name
NeuroCool Patches
Dosage form
PATCH
Route
TOPICAL
Labeler
Blue Heron Pharmaceuticals LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-13
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 mg/100mg; mg/100mg
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
NeuroCool Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 mg/100mg
MENTHOL1 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal 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
1249758Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
410c317c-abc3-f5da-e063-6394a90ab916Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85622-500-15NeuroCool Patches1 mg in 1 POUCHPATCH11
85622-500-15NeuroCool Patches15 in 1 BOXPATCH151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85622-500-15EA - Each85622-500fc439deb-f862-42ed-9abd-4173710f728a12026-01-08

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeuroCool PatchesNEUROCOOL PATCHESBlue Heron Pharmaceuticals LLC410c317c-abc3-f5da-e063-6394a90ab9162025-12-16WarningsExact identifier
ndc (product): 85622-500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN410c317c-abc3-f5da-e063-6394a90ab9161
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD410c317c-abc3-f5da-e063-6394a90ab9161
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY410c317c-abc3-f5da-e063-6394a90ab9161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85622-500-158562205001515 POUCH in 1 BOX (85622-500-15) / 1 mg in 1 POUCH15 pouch2025-10-13NoNoCurrent