FDA.reportPublic FDA data

Real Time Pain Relief Maxx Topical Analgesic

Product NDC
84573-517
11-digit product format
845730517
Labeler code
84573
Product ID
84573-517_2019e91f-7c9a-32bb-e063-6294a90ad6ba
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOTION
Route
TOPICAL
Labeler
REAL TIME PRODUCTS, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-12
Substance
MENTHOL
Active strength
15 mg/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
Real Time Pain Relief Maxx Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL15 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
1148429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f45eb95a-2813-4124-bdb0-54e078a8237dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84573-517-03Real Time Pain Relief Maxx Topical Analgesic88 mL in 1 TUBELOTION882
84573-517-04Real Time Pain Relief Maxx Topical Analgesic120 mL in 1 TUBELOTION1202
84573-517-05Real Time Pain Relief Maxx Topical Analgesic147.8 mL in 1 TUBELOTION147.82
84573-517-07Real Time Pain Relief Maxx Topical Analgesic210 mL in 1 TUBELOTION2102
84573-517-12Real Time Pain Relief Maxx Topical Analgesic354 mL in 1 TUBELOTION3542
84573-517-16Real Time Pain Relief Maxx Topical Analgesic473 mL in 1 TUBELOTION4732
84573-517-64Real Time Pain Relief Maxx Topical Analgesic1893 mL in 1 BOTTLELOTION18932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84573-517REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC (MENTHOL) LOTION [REAL TIME PRODUCTS, INC]2Current NDC, 7 package rows20240821_f45eb95a-2813-4124-bdb0-54e078a8237d.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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148429menthol 1.5 % Topical LotionPSNf45eb95a-2813-4124-bdb0-54e078a8237d2
1148429menthol 15 MG/ML Topical LotionSCDf45eb95a-2813-4124-bdb0-54e078a8237d2
1148429menthol 1.5 % Topical LotionSYf45eb95a-2813-4124-bdb0-54e078a8237d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84573-517-038457305170388 mL in 1 TUBE (84573-517-03) 88 ml2024-07-12NoNoCurrent
84573-517-0484573051704120 mL in 1 TUBE (84573-517-04) 120 ml2024-07-12NoNoCurrent
84573-517-0584573051705147.8 mL in 1 TUBE (84573-517-05) 147.8 ml2024-07-12NoNoCurrent
84573-517-0784573051707210 mL in 1 TUBE (84573-517-07) 210 ml2024-07-12NoNoCurrent
84573-517-1284573051712354 mL in 1 TUBE (84573-517-12) 354 ml2024-07-12NoNoCurrent
84573-517-1684573051716473 mL in 1 TUBE (84573-517-16) 473 ml2024-07-12NoNoCurrent
84573-517-64845730517641893 mL in 1 BOTTLE (84573-517-64) 1893 ml2024-08-16NoNoCurrent