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 76 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact identifier
application number: M017
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl ozMENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)BH GLOBAL HOLDINGS LLC1ddddbb6-2d01-c894-e063-6394a90acd582025-10-01WarningsExact identifier
application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
application number: M017
Capsaicin HeatCAPSAICINUniversal Distribution Center LLCb3b40f77-3b0b-4111-968b-f3a87a5701fa2025-09-29WarningsExact identifier
application number: M017
Caring Mills Menthol 4% Roll-OnMENTHOLVeridian Healthcaref4308c74-0860-4265-aeaf-a01301cca27a2025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED LARGEMENTHOLUniversal Distribution Center LLCd6780230-aa96-4055-b054-be41358568b62025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
application number: M017
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
Gutong Tiegao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD5a5c3759-90e0-4a93-99cf-ddbf00aba10d2025-09-26WarningsExact identifier
application number: M017
Zhuanggu Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTDe3e98530-ce4d-47b9-9383-3088814034eb2025-09-26WarningsExact identifier
application number: M017
GUTONG TIEGAO PAIN RELIEVINGCAMPHOR AND MENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3adfac16-ea7b-47df-89f5-91bbd09c4fe12025-09-26WarningsExact identifier
application number: M017
Xpect Sting WipesBENZOCAINE 6%Cintas Corporationfeeae00d-e266-4ae4-90d2-524da38fa8132025-09-26WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
application number: M017
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact 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