FDA.reportPublic FDA data

AsperFlex Advance

Product NDC
71399-4458
11-digit product format
713994458
Labeler code
71399
Product ID
71399-4458_40203da6-76b4-e5f5-e063-6394a90ab7b3
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl salicylate
Dosage form
PATCH
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Akron Pharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-04
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
86.24; 166.92; 278.2 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)86.24 mg/1
MENTHOL166.92 mg/1
METHYL SALICYLATE278.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui1793147

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
71399-4458-62025-10-01C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62024-07-30C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62023-02-19C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62023-01-30C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-4458-6AsperFlex Advance1 in 1 PATCHPATCH14
71399-4458-6AsperFlex Advance6 in 1 BOXPATCH64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-4458-6EA - Each71399-4458a38538b9-edd2-459f-92a9-a849a60c5ae312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-4458ASPERFLEX ADVANCE (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [AKRON PHARMA INC.]2Current NDC, Legacy NDC, 2 package rows20230220_d23d7f2b-4dcd-4c31-9d12-340f233018b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSNd23d7f2b-4dcd-4c31-9d12-340f233018b44
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDd23d7f2b-4dcd-4c31-9d12-340f233018b44
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSYd23d7f2b-4dcd-4c31-9d12-340f233018b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-4458-6713994458066 PATCH in 1 BOX (71399-4458-6) / 1 PATCH in 1 PATCH6 patch2021-11-040000-00-00NoNoCurrent