FDA.reportPublic FDA data

Advil Targeted Relief

Product NDC
0573-6555
11-digit product format
005736555
Labeler code
0573
Product ID
0573-6555_10e39c07-0913-c1b0-e063-6394a90aff82
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, capsaicin, menthol, methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-06
Substance
CAMPHOR (NATURAL); CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
31; .25; 100; 150 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Advil Targeted Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)31 mg/g
CAPSAICIN.25 mg/g
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE150 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN20HL7Q941, S07O44R1ZM, L7T10EIP3A, LAV5U5022Y
Rxcui2049725

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-6555-45Advil Targeted Relief71 g in 1 TUBE, WITH APPLICATORCREAM711
0573-6555-45Advil Targeted Relief1 in 1 CARTONCREAM11
0573-6555-48Advil Targeted Relief3 g in 1 POUCHCREAM31
0573-6555-51Advil Targeted Relief113.4 g in 1 TUBECREAM113.41
0573-6555-51Advil Targeted Relief1 in 1 CARTONCREAM11
0573-6555-54Advil Targeted Relief65 g in 1 TUBECREAM651
0573-6555-54Advil Targeted Relief1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-6555ADVIL TARGETED RELIEF (CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE) CREAM [HALEON US HOLDINGS LLC]1Current NDC, 7 package rows20240306_16e6be21-7b43-443a-89ec-3bdf0ec0dfc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049725camphor 3.1 % / capsaicin 0.025 % / menthol 10 % / methyl salicylate 15 % Topical CreamPSN16e6be21-7b43-443a-89ec-3bdf0ec0dfc11
2049725camphor 31 MG/ML / capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD16e6be21-7b43-443a-89ec-3bdf0ec0dfc11
2049725camphor 3.1 % / capsaicin 0.025 % / menthol 10 % / methyl salicylate 15 % Topical CreamSY16e6be21-7b43-443a-89ec-3bdf0ec0dfc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-6555-45005736555451 TUBE, WITH APPLICATOR in 1 CARTON (0573-6555-45) / 71 g in 1 TUBE, WITH APPLICATOR2024-03-06NoNoCurrent
0573-6555-48005736555483 g in 1 POUCH (0573-6555-48) 3 g2024-03-06NoNoCurrent
0573-6555-51005736555511 TUBE in 1 CARTON (0573-6555-51) / 113.4 g in 1 TUBE1 tube2024-03-06NoNoCurrent
0573-6555-54005736555541 TUBE in 1 CARTON (0573-6555-54) / 65 g in 1 TUBE1 tube2024-03-06NoNoCurrent