FDA.reportPublic FDA data

EMU THERAPY Cool Menthol Therapy Pain Relief Cream

Product NDC
83591-416
11-digit product format
835910416
Labeler code
83591
Product ID
83591-416_097667a6-8c92-70ba-e063-6294a90a7af0
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
ACA MANAGEMENT LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-08
Substance
MENTHOL
Active strength
27.5 mg/mL
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
EMU THERAPY Cool Menthol Therapy Pain Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL27.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2643471Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16894346-3513-41b1-b09f-72d84edcc4acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83591-416-00EMU THERAPY Cool Menthol Therapy Pain Relief Cream237 mL in 1 JARCREAM2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83591-416EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM (MENTHOL) CREAM [ACA MANAGEMENT LLC]4Current NDC, 1 package rows20231106_16894346-3513-41b1-b09f-72d84edcc4ac.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 58 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017
MilagrosoMETHYL SALICYLATEPharmadel LLCfdcc8f44-afa0-3af0-e053-6394a90aa46d2025-12-04WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
application number: M017
Pain RelievingTROLAMINE SALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb813262e-57c6-4d2c-8cc0-7a17f6f593432025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd38767081-7011-6602-e063-6394a90a27842025-12-03WarningsExact identifier
application number: M017
4% Lidocaine Maximum Strength Pain ReliefLIDOCAINEShenzhen Finona Information Technology Co., Ltd3e5a5165-a773-0501-e063-6294a90ae2f42025-12-03WarningsExact identifier
application number: M017
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
application number: M017
Westlake LidocaineLIDOCAINE HCLWestlake Pharma LLC0c586a14-1a2a-9f42-e063-6294a90a16c12025-12-03WarningsExact identifier
application number: M017
CVS Lidocaine Maximum StrengthLIDOCAINE HCLCVS Pharmacy87490c0f-a4d9-740e-e053-2a95a90a47242025-12-03WarningsExact identifier
application number: M017
CVS Maximum Strength BurnLIDOCAINE HYDROCHLORIDE 4%CVS Pharmacy4510f379-c5a4-92c3-e063-6294a90a0a322025-12-03WarningsExact identifier
application number: M017
LidoPatch Pain ReliefLIDOCAINE, MENTHOLJAR Laboratories07289aa1-43ed-df31-e063-6394a90a764a2025-12-03WarningsExact identifier
application number: M017
Equate Pain Relief Cream4% LIDOCAINE HCLWalmart, Inc7d8e8a9a-5474-4c7b-e053-2991aa0a29f52025-12-03WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation14f23c28-c713-4868-9f46-66363bf94b2c2025-12-03WarningsExact identifier
application number: M017
ElixirCortiReliefHYDROCORTISONEELIXIR HEALTHCARE USA, LLC.a6ca66f3-9759-4c98-a758-45700bc083522025-12-02WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Trifecta Pharmaceuticals USA, LLC.12a27ce7-c547-7134-e063-6394a90a94bd2025-12-02WarningsExact identifier
application number: M017
5Kind DMSOMENTHOL, METHYL SALICYLATE5KIND TRADING LTD6a6c7241-f544-4784-9581-f5b172fdbec72025-12-02WarningsExact identifier
application number: M017
PEDIADERMICS ECZEMA 2HYDROCORTISONERENU LABORATORIES, LLCda840bf6-ed65-bafc-e053-2a95a90a92d52025-12-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2643471menthol 2.75 % Topical CreamPSN16894346-3513-41b1-b09f-72d84edcc4ac4
2643471menthol 27.5 MG/ML Topical CreamSCD16894346-3513-41b1-b09f-72d84edcc4ac4
2643471menthol 2.75 % Topical CreamSY16894346-3513-41b1-b09f-72d84edcc4ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83591-416-0083591041600237 mL in 1 JAR (83591-416-00) 237 ml2023-08-08NoNoCurrent