FDA.reportPublic FDA data

Minnerva II

Product NDC
82718-2210
11-digit product format
827182210
Labeler code
82718
Product ID
82718-2210_de4a096f-33d4-35f1-e053-2a95a90a8ee7
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Epinephrine
Dosage form
GEL
Route
TOPICAL
Labeler
SofTap Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-05-11
Substance
EPINEPHRINE HYDROCHLORIDE; LIDOCAINE
Active strength
.004; .3 g/10g; g/10g
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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
Minnerva II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE HYDROCHLORIDE.004 g/10g
LIDOCAINE.3 g/10g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WBB047OO38Internal UNII lookup
98PI200987Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ddd34237-7770-19b3-e053-2995a90af775Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82718-2210-1Minnerva II10 g in 1 TUBEGEL102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82718-2210MINNERVA II (LIDOCAINE, EPINEPHRINE) GEL [SOFTAP INC]2Current NDC, Legacy NDC, 1 package rows20220511_ddd34237-7770-19b3-e053-2995a90af775.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minnerva IILIDOCAINE, EPINEPHRINESofTap Incddd34237-7770-19b3-e053-2995a90af7752022-05-05WarningsExact identifier
ndc (product): 82718-2210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82718-2210-18271822100110 g in 1 TUBE (82718-2210-1) 10 g2022-05-110000-00-00NoNoCurrent