ManaMed Lidocaine 4% Pain Relieving Gel Patch

Product NDC
82728-001
11-digit product format
827280001
Labeler code
82728
Product ID
82728-001_e21e6d49-b753-0364-e053-2a95a90afe33
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Manamed, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-06-22
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
4 g/1
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82728-001DDiscontinued by firm2026-08-11
excluded packagepackage82728-00182728-001-01DDiscontinued by firm2026-08-11

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82728-001-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82728-001-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82728-001-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82728-001MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH (LIDOCAINE) PATCH [MANAMED, INC.]4Legacy NDC20250115_78d8ba4d-e9bc-40ec-9eb4-7e715ac68d5c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82728-001-01827280001016 POUCH in 1 BOX (82728-001-01) > 1 PATCH in 1 POUCH6 pouch2022-06-220000-00-00NoNoCurrent