FDA.reportPublic FDA data

PAIN-X

Product NDC
80489-003
11-digit product format
804890003
Labeler code
80489
Product ID
80489-003_2b51e8c1-1805-573d-e063-6294a90a2f58
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
OL PHARMA TECH,LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
25 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
PAIN-X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM25 mg/g

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
282805Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b22bb19a-14e5-3d32-e053-2a95a90ae520Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-003-01PAIN-X1 in 1 CARTONGEL14
80489-003-01PAIN-X28.3 g in 1 TUBEGEL28.34
80489-003-02PAIN-X1 in 1 CARTONGEL14
80489-003-02PAIN-X49.6 g in 1 TUBEGEL49.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-003PAIN-X (MENTHOL) GEL [OL PHARMA TECH,LLC]4Current NDC, Legacy NDC, 4 package rows20250112_b22bb19a-14e5-3d32-e053-2a95a90ae520.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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL BREEZE Pain ReliefMENTHOLCOOL BREEZE US LLC14dcf4ee-6778-49d4-8601-9205737432ea2023-11-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP1ebb45e5-4541-4c95-abe1-661ef763a6102023-11-01WarningsExact identifier
application number: M017
Walgreens Pain Relieving CreamLIDOCAINE 4%Walgreensce1b55ed-f5c5-ea8b-e053-2a95a90acd402023-10-31WarningsExact identifier
application number: M017
Walgreens pain relievingLIDOCAINE 4%Walgreensce2b9e57-749d-715c-e053-2995a90aaf8d2023-10-31WarningsExact identifier
application number: M017
Walgreens Cool n heatLIDOCAINE 4% MENTHOL 1%Walgreensce168ab7-ec4a-daea-e053-2995a90af8292023-10-31WarningsExact identifier
application number: M017
Methyl Salicylate 40 PercentMETHYL SALICYLATEAlexso, Inc53407aab-094c-4393-a2b9-54fd85321e3e2023-10-31WarningsExact identifier
application number: M017
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282805menthol 2.5 % Topical GelPSNb22bb19a-14e5-3d32-e053-2a95a90ae5204
282805menthol 0.025 MG/MG Topical GelSCDb22bb19a-14e5-3d32-e053-2a95a90ae5204
282805menthol 2.5 % Topical GelSYb22bb19a-14e5-3d32-e053-2a95a90ae5204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-003-01804890003011 TUBE in 1 CARTON (80489-003-01) / 28.3 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent
80489-003-02804890003021 TUBE in 1 CARTON (80489-003-02) / 49.6 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent