FDA.reportPublic FDA data

Aspercreme with Lidocaine

Product NDC
41167-0585
11-digit product format
411670585
Labeler code
41167
Product ID
41167-0585_0c712675-53e0-42bb-a5d4-e0f673965865
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-21
Substance
LIDOCAINE
Active strength
422 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Aspercreme with Lidocaine
Brand name suffix
XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE422 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1737778

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0585-0Aspercreme with LidocaineXL3 in 1 CARTONPATCH38
41167-0585-0Aspercreme with LidocaineXL1 in 1 POUCHPATCH18
41167-0585-1Aspercreme with LidocaineXL4 in 1 CARTONPATCH48
41167-0585-1Aspercreme with LidocaineXL1 in 1 POUCHPATCH18
41167-0585-2Aspercreme with LidocaineXL1 in 1 POUCHPATCH18
41167-0585-2Aspercreme with LidocaineXL4 in 1 CARTONPATCH48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0585-0EA - Each41167-058559a0d2b2-1f89-491c-852c-986b7cf5c05812021-08-05
41167-0585-2EA - Each41167-0585704756a6-8511-4cfa-b0ed-66d4a2c0a2f912026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0585ASPERCREME WITH LIDOCAINE XL (LIDOCAINE) PATCH [CHATTEM, INC.]6Current NDC, Legacy NDC, 6 package rows20241102_b0859b10-539e-4905-ab52-af78b778d6a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNb0859b10-539e-4905-ab52-af78b778d6a48
1737778lidocaine 0.04 MG/MG Medicated PatchSCDb0859b10-539e-4905-ab52-af78b778d6a48
1737778lidocaine 4 % Medicated PatchSYb0859b10-539e-4905-ab52-af78b778d6a48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0585-0411670585003 POUCH in 1 CARTON (41167-0585-0) / 1 PATCH in 1 POUCH3 pouch2017-10-210000-00-00NoNoCurrent
41167-0585-1411670585014 POUCH in 1 CARTON (41167-0585-1) > 1 PATCH in 1 POUCH4 pouch2017-10-210000-00-00NoNoCurrent
41167-0585-2411670585024 POUCH in 1 CARTON (41167-0585-2) / 1 PATCH in 1 POUCH4 pouch2026-01-05NoNoHistorical