FDA.reportPublic FDA data

URIFLEX Fast Acting Analgesic Pain Relief

Product NDC
73168-004
11-digit product format
731680004
Labeler code
73168
Product ID
73168-004_09751fc7-6657-c196-e063-6294a90a4a57
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Rejuvica LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-20
Substance
MENTHOL
Active strength
45 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
URIFLEX Fast Acting Analgesic Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL45 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
2171392Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb78f705-b838-461d-b42c-8c98d3ca5d09Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73168-004-00URIFLEX Fast Acting Analgesic Pain Relief118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73168-004URIFLEX FAST ACTING ANALGESIC PAIN RELIEF (MENTHOL) CREAM [REJUVICA LLC]2Current NDC, Legacy NDC, 1 package rows20231106_fb78f705-b838-461d-b42c-8c98d3ca5d09.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 143 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC724b9870-e86a-4087-ba78-8c944ce3baa62023-11-28WarningsExact identifier
application number: M017
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
application number: M017
Thera Plus Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
application number: M017
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
application number: M017
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
application number: M017
BT Pain Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
application number: M017
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
application number: M017
Dit Da ShuiMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLC5d45cb48-3e88-4d58-81d2-6f88d7a821342023-11-20WarningsExact identifier
application number: M017
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2171392menthol 4.5 % Topical CreamPSNfb78f705-b838-461d-b42c-8c98d3ca5d092
2171392menthol 45 MG/ML Topical CreamSCDfb78f705-b838-461d-b42c-8c98d3ca5d092
2171392menthol 4.5 % Topical CreamSYfb78f705-b838-461d-b42c-8c98d3ca5d092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73168-004-0073168000400118 mL in 1 JAR (73168-004-00) 118 ml2019-05-200000-00-00NoNoCurrent