FDA.reportPublic FDA data

Real Time Pain Relief Maxx Plus Topical Analgesic

Product NDC
84573-547
11-digit product format
845730547
Labeler code
84573
Product ID
84573-547_26b61417-67ca-df12-e063-6394a90a79ef
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
2024-10-23
Substance
MENTHOL
Active strength
19 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 Plus Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL19 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc509a55-594d-4d44-87db-33286e937581Available 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
84573-547-03Real Time Pain Relief Maxx Plus Topical Analgesic88 mL in 1 TUBELOTION881
84573-547-04Real Time Pain Relief Maxx Plus Topical Analgesic120 mL in 1 TUBELOTION1201
84573-547-05Real Time Pain Relief Maxx Plus Topical Analgesic147.8 mL in 1 TUBELOTION147.81
84573-547-07Real Time Pain Relief Maxx Plus Topical Analgesic210 mL in 1 TUBELOTION2101
84573-547-12Real Time Pain Relief Maxx Plus Topical Analgesic354 mL in 1 BOTTLELOTION3541
84573-547-16Real Time Pain Relief Maxx Plus Topical Analgesic473 mL in 1 BOTTLELOTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84573-547REAL TIME PAIN RELIEF MAXX PLUS TOPICAL ANALGESIC (MENTHOL) LOTION [REAL TIME PRODUCTS INC.]1Current NDC, 6 package rows20241114_fc509a55-594d-4d44-87db-33286e937581.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 115 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact identifier
application number: M017
Walgreens Flexible Pain Relieving LidocaineLIDOCAINE, MENTHOLWalgreen Co.6f070fa3-a61a-4523-a470-ab58bf9400a32024-11-27WarningsExact identifier
application number: M017
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC884907a8-c884-4cce-ac10-9d4848fdba3e2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC7f067e95-e01c-4b9a-a02e-0af097beb18c2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC9ece9b3a-0092-4c1c-a913-c2fefcd705412024-11-22WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Cream Platinum 4% LidocaineLIDOCAINE 4%Telebrands Corp2788189e-35bc-d48c-e063-6294a90ae6c22024-11-21WarningsExact identifier
application number: M017
Family Wellness Ultra Strength Muscle RubULTRA STRENGTH MUSCLE RUBFAMILY DOLLAR (Family Wellness)554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a2024-11-21WarningsExact identifier
application number: M017
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
application number: M017
Family Wellness Hot and Cold Pain ReliefHOT AND COLD PAIN RELIEFFAMILY DOLLAR (Family Wellness)b70e343b-18aa-4e45-ae8e-79d8c84ad2052024-11-21WarningsExact identifier
application number: M017
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
application number: M017
WINCO HydrocortisoneHYDROCORTISONE 1%WinCo Foods LLC26a29de3-4b79-4a3a-93b6-a14c5e91a8c62024-11-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84573-547-038457305470388 mL in 1 TUBE (84573-547-03) 88 ml2024-10-23NoNoCurrent
84573-547-0484573054704120 mL in 1 TUBE (84573-547-04) 120 ml2024-10-23NoNoCurrent
84573-547-0584573054705147.8 mL in 1 TUBE (84573-547-05) 147.8 ml2024-10-23NoNoCurrent
84573-547-0784573054707210 mL in 1 TUBE (84573-547-07) 210 ml2024-10-23NoNoCurrent
84573-547-1284573054712354 mL in 1 BOTTLE (84573-547-12) 354 ml2024-10-23NoNoCurrent
84573-547-1684573054716473 mL in 1 BOTTLE (84573-547-16) 473 ml2024-10-23NoNoCurrent