FDA.reportPublic FDA data

TheraCare Pain Relieving Menthol Gel

Product NDC
71101-015
11-digit product format
711010015
Labeler code
71101
Product ID
71101-015_40ab4ec2-5e0b-2406-e063-6394a90a83ab
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 2%
Dosage form
GEL
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
MENTHOL
Active strength
2 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 Pain Relieving Menthol Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d2ccb02-746c-4cb9-905d-280987778f4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-015-01TheraCare Pain Relieving Menthol Gel1 in 1 BOXGEL11
71101-015-01TheraCare Pain Relieving Menthol Gel226.8 mL in 1 BOTTLEGEL226.81

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 139 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XRay Pain ReliefMENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATEGenomma Lab USA5244ddee-fd9e-4df3-8fb3-b16aa321a3162023-12-27WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Pharma Nobis, LLCe42fbe63-b01c-4f85-e053-2a95a90a51432023-12-26WarningsExact identifier
application number: M017
Equate CalasprayPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Walmart Inc027ed5ab-05ec-569f-e063-6394a90abbc32023-12-26WarningsExact identifier
application number: M017
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
application number: M017
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
application number: M017
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Itch Relief GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesicLIDOCAINE HYDROCHLORIDEWal-Mart Stores, Inc.bf954949-a7b7-44ba-8565-f1d5c0a6c0d12023-12-21WarningsExact identifier
application number: M017
Bactine Max BandageLIDOCAINEWellSpring Pharmaceutical Corporation465dc46e-6435-4569-9516-f648d0fe0f092023-12-21WarningsExact identifier
application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 0.02 MG/MG Topical GelSCD9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 2 % Topical GelSY9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 2 % topical stickSY9d2ccb02-746c-4cb9-905d-280987778f4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-015-01711010015011 BOTTLE in 1 BOX (71101-015-01) / 226.8 mL in 1 BOTTLE1 bottle2025-10-01NoNoCurrent