FDA.reportPublic FDA data

Lidocaine

Product NDC
87879-002
Requested package NDC
87879-002-02
11-digit product format
878790002
Labeler code
87879
Product ID
87879-002_572b955a-6819-6240-e063-6394a90a6a8b
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
GRANULE
Route
TOPICAL
Labeler
Shaanxi Shuvita Biotech Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-22
Substance
LIDOCAINE
Active strength
100 kg/100kg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE100 kg/100kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
572b95a1-11b2-6328-e063-6394a90acb73Available on FDA.report

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
LidocaineLIDOCAINEShaanxi Shuvita Biotech Co., Ltd572b95a1-11b2-6328-e063-6394a90acb732026-07-21WarningsExact identifier
ndc (package): 87879-002-02
ndc (product): 87879-002
ndc11 (package): 87879000202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87879-002-028787900020220 PAIL in 1 POUCH (87879-002-02) / 25 kg in 1 PAIL (87879-002-01) 20 pail2026-07-22NoNoCurrent