TopCare Pain Relieving Roll-On

Product NDC
36800-290
11-digit product format
368000290
Labeler code
36800
Product ID
36800-290_d6e69347-6255-4460-97e1-754359314327
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
40 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-290-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-290-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-290-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage36800-290-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage36800-290-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage36800-290-011332a3947898…d4bfe170f9cd…

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
TopCare Pain Relieving Roll-On
Brand name suffix
Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM40 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
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48589893-ca67-471d-88bc-92014295ab9fAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-290-01TopCare Pain Relieving Roll-OnTopical Analgesic74 mL in 1 BOTTLE, WITH APPLICATORGEL744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-290TOPCARE PAIN RELIEVING ROLL-ON TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 1 package rows20241115_48589893-ca67-471d-88bc-92014295ab9f.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 25 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoTapeLIDOCAINE 4%V2 Pharma LLCed18b4f7-6a2c-4dce-9b53-e485569093c52026-04-09WarningsExact identifier
application number: M017
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcare4f112ab2-b67a-a3e2-e063-6394a90acb602026-04-09WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare4f11aa1e-de53-a3b0-e063-6294a90a2fe42026-04-09WarningsExact identifier
application number: M017
TheraCare 2X Medicated Pain ReliefLIDOCAINE, MENTHOLVeridian Healthcare4f11fca1-1949-ab8e-e063-6394a90ac6272026-04-09WarningsExact identifier
application number: M017
TheraCare Medicated Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcare4f125062-af89-40d3-e063-6394a90a27ef2026-04-09WarningsExact identifier
application number: M017
DRMITSUI ECZEMA RELIEFHYDROCORTISONE 1% ECZEMA RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4eee7637-3a28-e0bd-e063-6294a90ae1a42026-04-08WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHORSinsin Pharmaceutical Co., Ltd.47c077c2-6e34-8e7a-e063-6294a90a21b52026-04-08WarningsExact identifier
application number: M017
Yi Tiao Gen Pain PatchPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory4828fe70-f6f8-45e4-9c9a-a9e486dc65e52026-04-07WarningsExact identifier
application number: M017
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsExact identifier
application number: M017
KinetiCream Pain Relieving Topical AnalgesicMENTHOLPhoenix Bioperformance Products LLCbb4c9e73-e62d-4b8c-a16c-b90db1a8b2a72026-04-06WarningsExact identifier
application number: M017
KinetiCream Anti-Inflammatory and Pain ReliefMENTHOLPhoenix Bioperformance Products LLC39a6d26b-b5f4-45d7-a9b5-6edbf42d75002026-04-06WarningsExact identifier
application number: M017
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN48589893-ca67-471d-88bc-92014295ab9f4
415974menthol 0.04 MG/MG Topical GelSCD48589893-ca67-471d-88bc-92014295ab9f4
415974menthol 4 % Topical GelSY48589893-ca67-471d-88bc-92014295ab9f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-290-013680002900174 mL in 1 BOTTLE, WITH APPLICATOR (36800-290-01) 74 ml2020-09-030000-00-00NoNoCurrent