Instaflex Pain Relief Cream

Product NDC
70015-665
11-digit product format
700150665
Labeler code
70015
Product ID
70015-665_51a0db5e-9e53-71c2-e063-6394a90a1bb2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Healthy Directions, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
MENTHOL
Active strength
12.5 mg/g
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 · 60 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 packagepackage70015-665-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70015-665-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70015-665-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70015-665-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70015-665-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70015-665-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70015-665-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70015-665-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70015-665-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70015-665-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70015-665-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70015-665-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70015-665-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70015-665-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70015-665-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70015-665-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70015-665-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70015-665-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70015-665-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70015-665-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70015-665-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70015-665-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70015-665-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70015-665-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70015-665-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70015-665-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70015-665-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70015-665-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70015-665-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70015-665-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70015-665-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70015-665-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70015-665-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70015-665-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70015-665-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70015-665-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70015-665-048af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70015-665-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70015-665-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70015-665-04834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70015-665-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70015-665-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70015-665-041332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70015-665-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70015-665-021332a3947898…d4bfe170f9cd…

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
Instaflex Pain Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.5 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
416982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
665b847a-9cfb-49fc-975b-81c97f936575Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-665-012024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-022024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-042024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-665-01Instaflex Pain Relief Cream28 g in 1 TUBECREAM283
70015-665-01Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream57 g in 1 TUBECREAM573
70015-665-04Instaflex Pain Relief Cream113 g in 1 TUBECREAM1133
70015-665-04Instaflex Pain Relief Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70015-665INSTAFLEX PAIN RELIEF CREAM (MENTHOL) CREAM [HEALTHY DIRECTIONS, LLC]2Current NDC, Legacy NDC, 6 package rows20200611_665b847a-9cfb-49fc-975b-81c97f936575.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 67 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIAN LI ZHUI FENG PAIN RELIEVINGCAMPHOR, MENTHOL, AND METHYL SALICYLATEMADISON ONE ACME INC03a4fb7c-2328-409d-99c8-cbcf2b4a451f2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATEDMENTHOL AND CAMPHORMADISON ONE ACME INC05c6b95a-aeb6-4234-97c7-8d77eccb38d82025-11-10WarningsExact identifier
application number: M017
HEI GUI PAIN RELIEVINGCAMPHOR AND METHYL SALICYLATEMADISON ONE ACME INC4140c404-edab-4923-941d-f74125e943a92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INCddcc814e-fcc4-4232-9ab4-826b8aac35f02025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
OvertimeMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.25fec070-8587-42d1-ba6f-1a9c150acc982025-11-10WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.05742cd5-ece2-4007-bdf0-46b76d23df742025-11-10WarningsExact identifier
application number: M017
Anal BluDESENSITIZERNovelties by Nasswalk, Inc.03b9555b-c3ff-4baa-e063-6394a90afb2c2025-11-10WarningsExact identifier
application number: M017
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSN665b847a-9cfb-49fc-975b-81c97f9365753
416982menthol 12.5 MG/ML Topical CreamSCD665b847a-9cfb-49fc-975b-81c97f9365753
416982menthol 1.25 % Topical CreamSY665b847a-9cfb-49fc-975b-81c97f9365753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70015-665-01700150665011 TUBE in 1 CARTON (70015-665-01) / 28 g in 1 TUBE1 tube2020-06-100000-00-00NoNoCurrent
70015-665-02700150665021 TUBE in 1 CARTON (70015-665-02) / 57 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent
70015-665-04700150665041 TUBE in 1 CARTON (70015-665-04) / 113 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent