ORCA Pain Reliever Putty with Menthol

Product NDC
82939-001
11-digit product format
829390001
Labeler code
82939
Product ID
82939-001_09ce4763-a8e6-7cff-e063-6294a90a851c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PASTE
Route
ORAL
Labeler
ORCA Products, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-15
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
8.4 mg/.525g
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82939-00182939-001-01DDiscontinued by firm2026-10-23

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 · 9 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…

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
ORCA Pain Reliever Putty with Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM8.4 mg/.525g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
188cb01a-3d0f-43d9-983e-6475c0c5b06eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82939-001-01ORCA Pain Reliever Putty with Menthol1 in 1 PACKAGEPASTE13
82939-001-01ORCA Pain Reliever Putty with Menthol4.2 g in 1 JARPASTE4.23
82939-001-02ORCA Pain Reliever Putty with Menthol1 in 1 BLISTER PACKPASTE13
82939-001-02ORCA Pain Reliever Putty with Menthol7 g in 1 JARPASTE73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82939-001ORCA PAIN RELIEVER PUTTY WITH MENTHOL (MENTHOL) PASTE [ORCA PRODUCTS, LLC]3Current NDC, Legacy NDC, 4 package rows20231111_188cb01a-3d0f-43d9-983e-6475c0c5b06e.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 27 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCe67b8def-c728-4952-9b35-874643cbe0f12025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCe628bd9f-99e5-4c71-ba8a-caa6c337de542025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCfef1f48c-e89d-4b75-9ba0-b1b068daf5822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalb18c2bfc-638e-40a7-8ecb-60303aa3f5192025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental64b9ebe6-afbe-4db2-b4bf-14ff5d007ea02025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalf5d37a12-9db1-4f2c-9dd1-72a8361e0e572025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalcb25c40b-07ef-44b8-9f48-0b8f3f78c8822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental3ad7867c-b584-4355-9fd7-7582919751bd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa7d4e2-9154-4c34-a1ec-d89231eda4472025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc385cc66-7d08-4b63-bfba-a133b5275c6d2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsddc81125-e12b-4170-938d-df7a624a7dfd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa1390b-d060-43a4-87ee-1497fa82e21b2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc78b5f2b-4434-4f36-82e3-781409db41622025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Products4545ab53-aa2d-41c4-9395-50bb64c196632025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCc113773b-dfb0-4797-ae0e-ecc06bfffd682025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLC31232583-180c-43d1-bc45-c3f6d9ea50812025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental4e68a4b9-a08c-4360-92b7-53d0f9df092d2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental103da78b-5de9-4fb4-9451-fd0269d296a52025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental833f0a44-dd32-4d5d-938d-fd56e7b23fcc2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental27772bcc-a338-4de4-8b16-cf647e4e08f62025-01-08WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82939-001-01829390001011 JAR in 1 PACKAGE (82939-001-01) > 4.2 g in 1 JAR1 jar2022-09-150000-00-00NoNoCurrent
82939-001-02829390001021 JAR in 1 BLISTER PACK (82939-001-02) / 7 g in 1 JAR1 jar2022-09-15NoNoCurrent