FDA.reportPublic FDA data

Pain Relief Gel-Tube

Product NDC
84008-003
11-digit product format
840080003
Labeler code
84008
Product ID
84008-003_42c9380a-3630-9175-e063-6294a90a5db9
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Bullet point LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-03
Substance
MENTHOL
Active strength
.04 g/mL
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 Relief Gel-Tube
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.04 g/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
42c93789-9758-54b7-e063-6394a90ac398Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84008-003-01Pain Relief Gel-Tube73 mL in 1 BOTTLEGEL731
84008-003-02Pain Relief Gel-Tube1 in 1 BOXGEL11

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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Endless Love for MenBENZOCAINEPRODUCT MAX GROUP INCd0fa792d-dc04-4bdf-a22d-dea896beae5b2023-11-10WarningsExact identifier
application number: M017
Endless Love For MenBENZOCAINEBody Action Products, Inc4e89cd3a-ecad-44c3-acb3-6d0810add8c02023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Higher Control Male ClimaxBENZOCAINEPRODUCT MAX GROUP INC3c7fa73b-abe8-4a8d-951c-4e785d6e812c2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC65a319a6-89d2-44c9-81d5-30327f9948cb2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC768f3f0e-1add-404f-b869-00a9f35ad34a2023-11-10WarningsExact identifier
application number: M017
Zcaine Fast Acting AnestheticLIDOCAINEPHI, Incd072243f-6ba6-4ab6-8ebf-a2381fa9c2df2023-11-09WarningsExact identifier
application number: M017
Plum Smooth Plumb Numb GeleeLIDOCAINEUniversal Companies, Inc.6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e2023-11-09WarningsExact identifier
application number: M017
Sonacaine Topical Anesthetic With MentholLIDOCAINEFilltech USA, LLCca54c6da-4bf2-4e63-ba7f-a69c4f9c431a2023-11-09WarningsExact identifier
application number: M017
Bed Bug Instant Bite ReliefLIDOCAINEP.F. Harris Mfg. Co. LLC7f472fd0-5605-4cc6-b4b2-1267e815255c2023-11-09WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN42c93789-9758-54b7-e063-6394a90ac3981
415974menthol 0.04 MG/MG Topical GelSCD42c93789-9758-54b7-e063-6394a90ac3981
415974menthol 4 % Topical GelSY42c93789-9758-54b7-e063-6394a90ac3981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84008-003-018400800030173 mL in 1 BOTTLE73 mlHistorical
84008-003-02840080003021 BOTTLE in 1 BOX (84008-003-02) / 73 mL in 1 BOTTLE (84008-003-01) 1 bottle2025-11-03NoNoCurrent