Point Relief Cold Spot Pain Relieving

Product NDC
51452-035
11-digit product format
514520035
Labeler code
51452
Product ID
51452-035_0fc4ec9e-6c21-5a8c-e063-6394a90a11ef
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Fabrication Enterprises
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
Substance
MENTHOL
Active strength
120 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51452-03551452-035-01DDiscontinued by firm2026-10-23
excluded packagepackage51452-03551452-035-04DDiscontinued by firm2026-10-23

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0551452-035-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0551452-035-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2651452-035-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2651452-035-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3151452-035-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3151452-035-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2851452-035-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2851452-035-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2151452-035-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2151452-035-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1051452-035-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1051452-035-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3151452-035-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3151452-035-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2051452-035-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2051452-035-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1051452-035-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1051452-035-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0851452-035-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0851452-035-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0351452-035-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0351452-035-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0951452-035-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0951452-035-04557ba5c1ecfa…9c80585c8c6e…

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
Point Relief Cold Spot Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL120 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
2121666Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad5d6f04-15e6-4548-95c2-32271c186bc1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-035-01Point Relief Cold Spot Pain Relieving120 mL in 1 BOTTLEGEL1204
51452-035-02Point Relief Cold Spot Pain Relieving475 mL in 1 BOTTLEGEL4754
51452-035-03Point Relief Cold Spot Pain Relieving3800 mL in 1 JUGGEL38004
51452-035-04Point Relief Cold Spot Pain Relieving420 mL in 1 TUBEGEL4204
51452-035-05Point Relief Cold Spot Pain Relieving950 mL in 1 BOTTLEGEL9504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-035POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES]4Current NDC, Legacy NDC, 5 package rows20240126_ad5d6f04-15e6-4548-95c2-32271c186bc1.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 147 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum Aerobic SportsSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC33f2491e-c1f2-4e5a-acbe-8ace844b88d62023-11-09WarningsExact identifier
application number: M017
Valtrum Topical Analgesic Roll OnSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC28167e2a-9afb-44e7-90c7-9577df9504b62023-11-09WarningsExact identifier
application number: M017
Satohap Cool TypeCAMPHOR, MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.fe07a00a-2699-44d3-887d-bd068948ad7b2023-11-07WarningsExact identifier
application number: M017
Hims Delay WipesBENZOCAINE WIPESHims Inc.adbead3d-dca0-4919-b688-44c88f779e5a2023-11-07WarningsExact identifier
application number: M017
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
application number: M017
Arth RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and LavenderHISTAMINE DIHYDROCHLORIDEBAKER'S BEST HEALTH PRODUCTS, INC.03ec87c5-6669-4afb-8d9c-c8dc9907495d2023-11-06WarningsExact identifier
application number: M017
DOCTORS TOUCH Erase The PainMENTHOLDOCTOR'S CHOICE MEDICAL, LLCfe9ce2c7-d6af-4dad-b6e6-5049a9e091b02023-11-06WarningsExact identifier
application number: M017
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121666menthol 0.12 MG/MG Topical GelPSNad5d6f04-15e6-4548-95c2-32271c186bc14
2121666menthol 0.12 MG/MG Topical GelSCDad5d6f04-15e6-4548-95c2-32271c186bc14
2121666menthol 12 % Topical GelSYad5d6f04-15e6-4548-95c2-32271c186bc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51452-035-0151452003501120 mL in 1 BOTTLE (51452-035-01) 120 ml2019-04-010000-00-00NoNoCurrent
51452-035-0251452003502475 mL in 1 BOTTLE (51452-035-02) 475 ml2019-04-010000-00-00NoNoCurrent
51452-035-03514520035033800 mL in 1 JUG (51452-035-03) 3800 ml2019-04-010000-00-00NoNoCurrent
51452-035-0451452003504420 mL in 1 TUBE (51452-035-04) 420 ml2019-04-010000-00-00NoNoCurrent
51452-035-0551452003505950 mL in 1 BOTTLE (51452-035-05) 950 ml2019-04-010000-00-00NoNoCurrent