FDA.reportPublic FDA data

Rugby Ice Blue

Product NDC
0536-1061
11-digit product format
005361061
Labeler code
0536
Product ID
0536-1061_3a605963-eddd-4402-b75c-a308ef688cb0
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-20
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct0536-1061EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-10610536-1061-39EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Rugby Ice Blue
Brand name suffix
External Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM20 mg/g

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
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b65cb6a-4364-4770-b7b9-5c4637edd01aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1061-392020-03-20C16284748780-19d75b9d1-09ed-f424-e053-dadaa90a57ceRugby ® Ice Blue Gel External Analgesic
0536-1061-392020-01-31C16284748780-19d75b9d1-09ed-f424-e053-dadaa90a57ceRugby ® Ice Blue Gel External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1061-39Rugby Ice BlueExternal Analgesic226.8 g in 1 JARGEL226.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1061-39GM - Gram0536-1061e9f23715-1a08-496d-8632-9ca7714b1fc912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ARUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ARUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
AmmoniaINACTIVE INGREDIENT5138Q19F1XRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
Cupric SulfateINACTIVE INGREDIENTLRX7AJ16DTRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
Magnesium Sulfate AnhydrousINACTIVE INGREDIENTML30MJ2U7IRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
ThymolINACTIVE INGREDIENT3J50XA376ERUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RRUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1061RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [RUGBY LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20240316_2b65cb6a-4364-4770-b7b9-5c4637edd01a.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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN2b65cb6a-4364-4770-b7b9-5c4637edd01a5
311502menthol 0.02 MG/MG Topical GelSCD2b65cb6a-4364-4770-b7b9-5c4637edd01a5
311502menthol 2 % Topical GelSY2b65cb6a-4364-4770-b7b9-5c4637edd01a5
311502menthol 2 % topical stickSY2b65cb6a-4364-4770-b7b9-5c4637edd01a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1061-3900536106139226.8 g in 1 JAR (0536-1061-39) 226.8 g2015-01-200000-00-00NoNoCurrent