Zylotrol Maximum Pain Patch

Product NDC
81902-101
Requested package NDC
81902-101-15
11-digit product format
819020101
Labeler code
81902
Product ID
81902-101_c85c3ee8-167a-efdb-e053-2a95a90a5710
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%, Menthol 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
Whitestone Products LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-07-30
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
4 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage81902-10181902-101-15DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage81902-10181902-101-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage81902-10181902-101-15DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-101-15EA - Each81902-10150ecf376-67cd-4d9b-bc6b-08a3511d5e3012021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81902-101-158190201011515 PATCH in 1 BOX (81902-101-15) > 4 g in 1 PATCH15 patch2021-07-300000-00-00NoNoCurrent