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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact 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