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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact 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