TheraCare Roll-on Menthol 4% Pain Relief

Product NDC
71101-090
11-digit product format
711010090
Labeler code
71101
Product ID
71101-090_3f694987-bd01-d332-e063-6294a90a5b1f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
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
TheraCare Roll-on Menthol 4% Pain Relief
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
fa121e5f-94b5-4c1d-9c4e-85bb8ede3945Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-090-01TheraCare Roll-on Menthol 4% Pain Relief73 mL in 1 BOTTLE, WITH APPLICATORGEL731
71101-090-01TheraCare Roll-on Menthol 4% Pain Relief1 in 1 CARTONGEL11

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 148 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS NATURAL PAINMENTHOLThe Feel Good Lab778b62a1-ebd3-4a30-8f76-6d6773b698c52023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLThe Feel Good Lab103c5e33-42fb-41ac-957e-bb46d85e204c2023-11-05WarningsExact identifier
application number: M017
INSTA RELIEF DMLIDOCAINE HYDROCHLORIDE, MENTHOLDM LAB CORP6ef66fb9-9f49-409d-9503-175c7555ee9e2023-11-05WarningsExact identifier
application number: M017
DR. MIKES Ponos Pain Relief Cream Roll-OnHISTAMINE DIHYDROCHLORIDE, MENTHOLDr. Mike's Vitamins, LLCfcc45464-f1fe-4244-95a7-9b4288b0ce452023-11-05WarningsExact identifier
application number: M017
AcuPlus Pain ReliefMENTHOLInnovations for Wellness, LLC7f222a4f-85a8-4f3d-aa97-5c695d4da37f2023-11-05WarningsExact identifier
application number: M017
Ana Cool Rapid Soothing Cooling FormulaHYDROCORTISONEAna-Cool, LLC64b80cc2-e2d8-4535-aaf8-c031f4159cd12023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLTHE FEEL GOOD LAB, LLC19b08cbf-5f43-4f07-8f4d-8cddb1492ab82023-11-05WarningsExact identifier
application number: M017
PlayMakar Roll On Cool Pain ReliefMENTHOLPlayMakar Inc.a12c16e7-561f-45a7-93c6-34d693ffdc7c2023-11-05WarningsExact identifier
application number: M017
AcuPlus Advanced Therapy for Pain and RecoveryMENTHOLINNOVATIONS FOR WELLNESS, LLC840cfd15-4ea1-49bf-8c4f-86c12461d8602023-11-05WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71101-090-01711010090011 BOTTLE, WITH APPLICATOR in 1 CARTON (71101-090-01) / 73 mL in 1 BOTTLE, WITH APPLICATOR2025-09-01NoNoCurrent