Home NDC 82939-001 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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…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 Ingredient Strength MENTHOL, UNSPECIFIED FORM 8.4 mg/.525g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82939-001-01 ORCA Pain Reliever Putty with Menthol 1 in 1 PACKAGE PASTE 1 3 82939-001-01 ORCA Pain Reliever Putty with Menthol 4.2 g in 1 JAR PASTE 4.2 3 82939-001-02 ORCA Pain Reliever Putty with Menthol 1 in 1 BLISTER PACK PASTE 1 3 82939-001-02 ORCA Pain Reliever Putty with Menthol 7 g in 1 JAR PASTE 7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82939-001 ORCA PAIN RELIEVER PUTTY WITH MENTHOL (MENTHOL) PASTE [ORCA PRODUCTS, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20231111_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 20 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topco Associates LLC Maximum Strength FLUORIDE Topco Associates LLC ac398ff0-0010-4e13-8b89-dc986fd7f974 2025-08-08 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE PLUS SOOTHING ALOE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 2025-07-30 Warnings Exact identifier application number: M022 Aseptil Rojo PHENOL Menper Distributors, Inc. 62c96dc1-4698-43c1-8e6d-f4062dc5eea2 2025-07-22 Warnings Exact identifier application number: M022 Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 Warnings Exact identifier application number: M022 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY WORLD DENTISTS ASSOCIATION AMERICA LIMITED 3573f149-2af9-4c86-e063-6294a90a7b3f 2025-05-18 Warnings Exact identifier application number: M022 Hydrogen Peroxide HYDROGEN PEROXIDE Safeway, Inc. 8fe2f1df-3264-455d-b62c-953dce171c02 2025-05-16 Warnings Exact identifier application number: M022 Parodontax Active Gum Health Daily Mouthwash Breath Freshener CETYLPYRIDINIUM CHLORIDE Haleon US Holdings LLC 32b632bf-058d-447b-a7fb-a9dd05c1e2b8 2025-05-08 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82939-001-01 82939000101 1 JAR in 1 PACKAGE (82939-001-01) > 4.2 g in 1 JAR 1 jar 2022-09-15 0000-00-00 No No Current 82939-001-02 82939000102 1 JAR in 1 BLISTER PACK (82939-001-02) / 7 g in 1 JAR 1 jar 2022-09-15 No No Current