FDA.reportPublic FDA data

Muscle Rub Pain Reliever Gel

Product NDC
52000-072
11-digit product format
520000072
Labeler code
52000
Product ID
52000-072_db1541b7-b2be-4751-a391-f0966f834ca3
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Centre LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-24
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
25 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52000-072IInactivated by FDA2026-10-20
excluded packagepackage52000-07252000-072-02IInactivated by FDA2026-10-20

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-072-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-072-02f5e01cc5f278…a2eaf40c39c3…

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
Muscle Rub Pain Reliever Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM25 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
282805Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
18536e21-afc3-8447-e063-6394a90aabaeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-072-022025-07-29C16284748780-13b156c62-308b-fb37-e063-e6dba90a4e07Pain Reliever Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-072-01Muscle Rub Pain Reliever Gel35.4 g in 1 TUBEGEL35.44
52000-072-02Muscle Rub Pain Reliever Gel1 in 1 CARTONGEL14
52000-072-03Muscle Rub Pain Reliever Gel35.4 g in 1 TUBEGEL35.43
52000-072-04Muscle Rub Pain Reliever Gel1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-072MUSCLE RUB PAIN RELIEVER GEL (MENTHOL, UNSPECIFIED FORM) GEL [UNIVERSAL DISTRIBUTION CENTRE LLC]4Current NDC, Legacy NDC, 2 package rows20241212_b9a563b6-7988-79df-e053-2995a90a752b.zip
52000-072MUSCLE RUB PAIN RELIEVER GEL (MENTHOL, UNSPECIFIED FORM) GEL [UNIVERSAL DISTRIBUTION CENTRE LLC]2Current NDC, Legacy NDC, 2 package rows20241218_18536e21-afc3-8447-e063-6394a90aabae.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 102 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLCd4276749-eeff-28f7-e053-2a95a90a593d2025-01-31WarningsExact identifier
application number: M017
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
application number: M017
Maximum Strength Blue Emu Pain Relief Blu EmuTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC5e02b820-e53a-42cb-abdb-2925617c29ca2025-01-31WarningsExact identifier
application number: M017
Sunset Novelties HerquakeNUMBING LUBRICANTSUNSET INTIMATES GROUP INC2ceeca3e-9197-9166-e063-6394a90ae9082025-01-30WarningsExact identifier
application number: M017
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282805menthol 2.5 % Topical GelPSNb9a563b6-7988-79df-e053-2995a90a752b4
282805menthol 0.025 MG/MG Topical GelSCDb9a563b6-7988-79df-e053-2995a90a752b4
282805menthol 2.5 % Topical GelSYb9a563b6-7988-79df-e053-2995a90a752b4
282805menthol 2.5 % Topical GelPSN18536e21-afc3-8447-e063-6394a90aabae3
282805menthol 0.025 MG/MG Topical GelSCD18536e21-afc3-8447-e063-6394a90aabae3
282805menthol 2.5 % Topical GelSY18536e21-afc3-8447-e063-6394a90aabae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-072-015200000720135.4 g in 1 TUBE35.4 gHistorical
52000-072-02520000072021 TUBE in 1 CARTON (52000-072-02) > 35.4 g in 1 TUBE (52000-072-01) 1 tube2021-01-240000-00-00NoNoCurrent
52000-072-035200000720335.4 g in 1 TUBE35.4 gHistorical
52000-072-04520000072041 TUBE in 1 CARTON (52000-072-04) / 35.4 g in 1 TUBE (52000-072-03) 1 tube2021-01-24NoNoCurrent