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 firm2026-10-15
excluded packagepackage51452-03551452-035-04DDiscontinued by firm2026-10-15

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 32 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HQLSEY QUIT SMOKING PATCHESQUIT SMOKING PATCHESHansen Pharmaceutical Investment Co., Limited4ba317fb-714a-05cb-e063-6394a90a382f2026-02-25WarningsExact identifier
application number: M017
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
application number: M017
Walgreens Pain Relieving PatchMENTHOL, CAMPHOR, METHYL SALICYLATEWalgreen Co.4223c74a-12fb-51a3-e063-6294a90a0deb2026-02-25WarningsExact identifier
application number: M017
Advanced Pain Relief Roll-On Gel With 5% Natural MentholMENTHOLAllure Labs4bad597f-acb2-a122-e063-6394a90a9fcf2026-02-25WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited4bade8a9-43bd-b649-e063-6294a90a81da2026-02-25WarningsExact identifier
application number: M017
dermaFIT Muscle Retention Cream StrengthMENTHOLEX Healthcare Inc.4620c41a-2187-00f5-e063-6394a90a613c2026-02-23WarningsExact identifier
application number: M017
dermaFIT Muscle Retention Cream SculptMENTHOLEX Healthcare Inc.4620d4ca-42e4-eeae-e063-6394a90a5c842026-02-23WarningsExact identifier
application number: M017
dermaFIT Muscle Retention Cream Extra StrengthMENTHOLEX Healthcare Inc.4620ca7a-afe6-d063-e063-6394a90ab5db2026-02-23WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESportpharm LLC9578b39e-3df7-4d75-abd7-f1d5524545e52026-02-23WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.cf723c7b-495d-4bae-942c-561cf28af2d32026-02-21WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamMENTHOL 1%GENUINE INNOVATION LTD4b2ebff2-2f50-e54b-e063-6294a90aaccb2026-02-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain RelievingMENTHOLWalmart Inc46a3c9e9-5cd3-4bc4-e063-6394a90a71782026-02-19WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEMeijer, Inc.e11390ec-99a3-4ff1-a3c8-ca909f4f67b52026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
application number: M017
Veiurkiu External Analgesic CreamLIDOCAINEBLOOMWELL GARDENS LLC40ec5e6f-13dc-de04-e063-6294a90af5d52026-02-18WarningsExact identifier
application number: M017
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
application number: M017
PAINGELMENTHOL, METHYL SALICYLATENACOR BUSINESS GROUP LLC4b1d55e2-cf83-ffbd-e063-6294a90ad52f2026-02-18WarningsExact identifier
application number: M017
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMedrock Pharmacy LLC43e00e17-1a48-43db-9589-834568917bbf2026-02-17WarningsExact 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