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_5a5dead1-f041-4e5b-acb4-30ff321647d6
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
2027-12-31
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 FDA2026-10-23
excluded packagepackage52000-07252000-072-02IInactivated by FDA2026-10-23

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 141 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
application number: M017
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact 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