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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2049725Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16e6be21-7b43-443a-89ec-3bdf0ec0dfc1Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-6555-45GM - Gram0573-65558b4db8c0-c9bf-4f23-89ac-c6ce2f662bd012025-02-10
0573-6555-51GM - Gram0573-6555f91d8b8e-8181-49bc-ab54-c8628a59776c12025-02-10
0573-6555-54GM - Gram0573-6555923be87b-29df-4d59-bc32-8f61e8bced9512025-02-10

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 59 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017

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