FDA.reportPublic FDA data

AsperFlex

Product NDC
71399-4456
11-digit product format
713994456
Labeler code
71399
Product ID
71399-4456_bc8a5183-bc62-4d5b-8276-3a8e4c710b73
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-04
Substance
LIDOCAINE
Active strength
4 g/100g
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

Additional Listing Data#

Finished product
Yes
Brand name base
AsperFlex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1737778

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-4456-52025-02-11C16284748780-1f386c64a-0d23-0266-e053-dadaa90a7c1aAspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-52024-07-30C16284748780-1f386c64a-0d23-0266-e053-dadaa90a7c1aAspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-52023-02-19C16284748780-1f386c64a-0d23-0266-e053-dadaa90a7c1aAspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-52023-01-30C16284748780-1f386c64a-0d23-0266-e053-dadaa90a7c1aAspeFlex Tough on Pain Lidocaine Patch 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-4456-3AsperFlex0.246 g in 1 PATCHPATCH0.2463
71399-4456-3AsperFlex30 in 1 CARTONPATCH303
71399-4456-5AsperFlex5 in 1 CARTONPATCH53
71399-4456-5AsperFlex0.246 g in 1 PATCHPATCH0.2463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-4456-3EA - Each71399-4456c609add2-cdb7-4c61-baa0-c4714783258212025-10-14
71399-4456-5EA - Each71399-445690427270-bab0-4662-a935-89631eaa395112022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-4456ASPERFLEX (LIDOCAINE) PATCH [AKRON PHARMA INC.]3Current NDC, Legacy NDC, 4 package rows20250214_ab50525e-b534-452b-8c25-2992c0cbf862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNab50525e-b534-452b-8c25-2992c0cbf8623
1737778lidocaine 0.04 MG/MG Medicated PatchSCDab50525e-b534-452b-8c25-2992c0cbf8623
1737778lidocaine 4 % Medicated PatchSYab50525e-b534-452b-8c25-2992c0cbf8623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-4456-37139944560330 PATCH in 1 CARTON (71399-4456-3) / .246 g in 1 PATCH30 patch2025-02-06NoNoCurrent
71399-4456-5713994456055 PATCH in 1 CARTON (71399-4456-5) / .246 g in 1 PATCH5 patch2021-11-040000-00-00NoNoCurrent