FDA.reportPublic FDA data

Signature Care Menthol

Product NDC
21130-824
11-digit product format
211300824
Labeler code
21130
Product ID
21130-824_2886fdc2-c077-87b5-e063-6394a90afc0a
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 4%
Dosage form
GEL
Route
TOPICAL
Labeler
Safeway
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
MENTHOL
Active strength
4 g/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
Signature Care Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27d3cb47-a6c7-5b7a-e063-6394a90a056fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-824-01Signature Care Menthol73 mL in 1 BOTTLEGEL732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-824SIGNATURE CARE MENTHOL (MENTHOL 4%) GEL [SAFEWAY]2Current NDC, 1 package rows20241208_27d3cb47-a6c7-5b7a-e063-6394a90a056f.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-824-012113008240173 mL in 1 BOTTLE (21130-824-01) 73 ml2024-12-01NoNoCurrent