Rematex

Product NDC
69379-035
11-digit product format
693790035
Labeler code
69379
Product ID
69379-035_1a8b55af-1cf1-1567-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Rematex Pain RelievingCream
Dosage form
CREAM
Route
TOPICAL
Labeler
Home Aide Diagnostics, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-07-01
Marketing end
0000-00-00
Substance
MENTHOL; METHYL SALICYLATE; CAPSAICIN
Active strength
6 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69379-035IInactivated by FDA2026-10-05
excluded packagepackage69379-03569379-035-01DDiscontinued by firm2026-10-05

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69379-035-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69379-035-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69379-035-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69379-035-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69379-035-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69379-035-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69379-035-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69379-035-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69379-035-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69379-035-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69379-035-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69379-035-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69379-035-012020-01-31C16284748780-19d75b9d0-f6a0-f424-e053-dadaa90a57ceRematex Pain Relieiving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-035-01Rematex120 g in 1 BOTTLE, PUMPCREAM1204

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
CAPSAICINACTIVE MOIETYS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4
CAPSAICINACTIVE INGREDIENTS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
MENTHOLACTIVE INGREDIENTL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
CAPSAICINACTIVE MOIETYS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
MENTHOLACTIVE MOIETYL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]3
CAPSAICINACTIVE INGREDIENTS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
CAPSAICINACTIVE INGREDIENTS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-035REMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4Legacy NDC, 1 package rows20150711_1a8b55af-1cf0-1567-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655506capsaicin 0.035 % / menthol 6 % / methyl salicylate 30 % Topical CreamPSN1a8b55af-1cf0-1567-e054-00144ff88e884
1655506capsaicin 0.35 MG/ML / menthol 60 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD1a8b55af-1cf0-1567-e054-00144ff88e884
1655506capsaicin 0.035 % / menthol 6 % / methyl salicylate 30 % Topical CreamSY1a8b55af-1cf0-1567-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69379-035-0169379003501120 g in 1 BOTTLE, PUMP120 gHistorical