Relief Pain Relieving Cream

Product NDC
58559-001
Requested package NDC
58559-001-01
11-digit product format
585590001
Labeler code
58559
Product ID
58559-001_48617c36-0ba4-cc34-e063-6394a90a0f20
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Corganics, LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-22
Substance
MENTHOL
Active strength
2.5 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 22 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
Relief Pain Relieving Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.5 g/100g

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
1291226Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85814fff-35f8-447f-b669-87eaf55e9859Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58559-001-012026-01-15DRUG FACTS
58559-001-022026-01-15DRUG FACTS
58559-001-032026-01-15DRUG FACTS
58559-001-042026-01-15DRUG FACTS
58559-001-052026-01-15DRUG FACTS
58559-001-012020-01-31DRUG FACTS
58559-001-022020-01-31DRUG FACTS
58559-001-032020-01-31DRUG FACTS
58559-001-042020-01-31DRUG FACTS
58559-001-052020-01-31DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58559-001-01Relief Pain Relieving Cream5 g in 1 BLISTER PACKCREAM52
58559-001-02Relief Pain Relieving Cream82 g in 1 BOTTLE, WITH APPLICATORCREAM822
58559-001-03Relief Pain Relieving Cream115 g in 1 TUBECREAM1152
58559-001-04Relief Pain Relieving Cream450 g in 1 BOTTLE, PUMPCREAM4502
58559-001-05Relief Pain Relieving Cream3600 g in 1 BOTTLE, PUMPCREAM36002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ARELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
MENTHOLACTIVE MOIETYL7T10EIP3ARELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ALOEINACTIVE INGREDIENTV5VD430YW9RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
PALMAROSA OILINACTIVE INGREDIENT0J3G3O53STRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
WATERINACTIVE INGREDIENT059QF0KO0RRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58559-001RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1Current NDC, Legacy NDC, 5 package rows20141119_85814fff-35f8-447f-b669-87eaf55e9859.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 1 of 156 · 3,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291226menthol 2.5 % Topical CreamPSN85814fff-35f8-447f-b669-87eaf55e98592
1291226menthol 25 MG/ML Topical CreamSCD85814fff-35f8-447f-b669-87eaf55e98592
1291226menthol 2.5 % Topical CreamSY85814fff-35f8-447f-b669-87eaf55e98592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58559-001-01585590001015 g in 1 BLISTER PACK (58559-001-01) 5 g2004-05-22NoNoCurrent