Arthritis Relief

Product NDC
65121-121
Requested package NDC
65121-121-43
11-digit product format
651210121
Labeler code
65121
Product ID
65121-121_482d946f-62c3-0db3-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, HISTAMINE DIHYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Pure Source, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-11-25
Marketing end
0000-00-00
Substance
MENTHOL; HISTAMINE DIHYDROCHLORIDE
Active strength
3 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65121-12165121-121-43DDiscontinued by firm2026-11-06

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644UARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
HISTAMINEACTIVE MOIETY820484N8I3ARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
EMU OILINACTIVE INGREDIENT344821WD61ARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
GLUCOSAMINE HYDROCHLORIDEINACTIVE INGREDIENT750W5330FYARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
LICORICEINACTIVE INGREDIENT61ZBX54883ARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
LIDOCAINE HYDROCHLORIDEINACTIVE INGREDIENTV13007Z41AARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RARTHRITIS RELIEF (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-121-436512101214356.7 g in 1 JAR (65121-121-43) 56.7 g2017-02-090000-00-00NoNoCurrent