Home NDC 84338-001 Pain Relieving Cream
Product NDC 84338-001
11-digit product format 843380001
Labeler code 84338
Product ID 84338-001_2fb7560c-6512-6b79-e063-6394a90a5e24
Type HUMAN OTC DRUG
Nonproprietary name Camphor and Menthol
Dosage form CREAM
Route TOPICAL
Labeler PAIN WIZARD LIMITED LIABILITY COMPANY
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-12-02
Substance CAMPHOR (SYNTHETIC); MENTHOL
Active strength 3; 3 mg/100mL; mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Pain Relieving Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 3 mg/100mL MENTHOL 3 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84338-001-16 Pain Relieving Cream 236 mL in 1 TUBE CREAM 236 4 84338-001-23 Pain Relieving Cream 473.17 mL in 1 BOTTLE, PUMP CREAM 473.17 4 84338-001-30 Pain Relieving Cream 59.14 mL in 1 TUBE CREAM 59.14 4 84338-001-92 Pain Relieving Cream 118.29 mL in 1 TUBE CREAM 118.29 4 84338-001-09 Pain Relieving Cream 88.7 mL in 1 BOTTLE, WITH APPLICATOR CREAM 88.7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84338-001 PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [PAIN WIZARD LIMITED LIABILITY COMPANY] 4 Current NDC, 4 package rows 20250309_1cd37b69-2cfb-130d-e063-6394a90af50b.zip 84338-001 PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [PAIN WIZARD LIMITED LIABILITY COMPANY] 1 Current NDC, 1 package rows 20241109_2647bba1-87f4-3c16-e063-6394a90ae0c9.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 90 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Curist 5% Lidocaine LIDOCAINE 5% Little Pharma, Inc. f20241a2-c5b1-f124-e053-2995a90a891b 2025-06-16 Warnings Exact identifier application number: M017 Toast Screamin Menthol MENTHOL IDEAZ, LLC 37b48b1a-ef3d-afdc-e063-6294a90a6610 2025-06-16 Warnings Exact identifier application number: M017 Toast Freezin Cold MENTHOL, METHYL SALICYLATE IDEAZ, LLC 37b4d363-0099-8cd3-e063-6394a90a18d6 2025-06-16 Warnings Exact identifier application number: M017 Earths Care Anti-Itch CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM DLC Laboratories, Inc. ba65f58a-d590-498a-b8e7-a3d78935d880 2025-06-13 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc 5eb6574c-2066-4390-befc-8e5d2dd6ede2 2025-06-12 Warnings Exact identifier application number: M017 CHINESE RED TIGER LIDOCAINE PATCHES 4% LIDOCAINE, 1%MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36b9a7a2-5832-4ce5-e063-6294a90aed12 2025-06-12 Warnings Exact identifier application number: M017 PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 375bc794-3289-e610-e063-6294a90a4f9b 2025-06-12 Warnings Exact identifier application number: M017 Methyl Salicylate 10% Pain Relieving METHYL SALICYLATE PureTek Corporation 376493eb-5142-db6d-e063-6294a90a1e73 2025-06-12 Warnings Exact identifier application number: M017 Free and Pure Cold Therapy Pain Relief MENTHOL Walgreen Co. 22cbbffc-f876-411e-e063-6394a90a1b38 2025-06-12 Warnings Exact identifier application number: M017 Methylten 25% Pain Relieving METHYL SALICYLATE PureTek Corporation 3767b97e-ab0c-ac26-e063-6394a90a00cf 2025-06-12 Warnings Exact identifier application number: M017 SPF 50 Mineral Sunscreen ZINC OXIDE Inspec Solutions, LLC 36af9a0a-536b-ee1a-e063-6394a90aace4 2025-06-11 Warnings Exact identifier application number: M017 PLANTAR FASCIITIS Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 37570149-dae1-a4f2-e063-6294a90a3245 2025-06-11 Warnings Exact identifier application number: M017 Diabecin CS Cream MENTHOL, CAPSAICIN Puretek Corporation 33ef2233-7a66-ee65-e063-6294a90ac55a 2025-06-10 Warnings Exact identifier application number: M017 KINKAN COOL DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL KINKANDO CO., LTD . 82011efe-825c-4102-b6f1-59eff4c8040a 2025-06-10 Warnings Exact identifier application number: M017 MQUPIN Knee Patch KNEE PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 37438a70-dab7-ecb5-e063-6394a90afefb 2025-06-10 Warnings Exact identifier application number: M017 ORTHOGEL Menthol 3.5% Roll On MENTHOL LiquidCapsule Manufacturing LLC 99424327-67e9-43b5-a117-94c9643413c1 2025-06-07 Warnings Exact identifier application number: M017 Lightning Pain Relief MENTHOL Ebanel Laboratories, Inc 36edbc3f-501c-c1ea-e063-6394a90af6af 2025-06-06 Warnings Exact identifier application number: M017 FREEZE IT Menthol Roll On MENTHOL LiquidCapsule Manufacturing LLC 33094afe-db9d-4b92-8047-6dd611484fc9 2025-06-05 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d55e6b09-0587-61a9-e053-2995a90afaf5 2025-06-05 Warnings Exact identifier application number: M017 FREEZE IT Menthol MENTHOL LiquidCapsule Manufacturing LLC de8d8007-5718-4fb4-a8c6-4650d2ca9c8f 2025-06-05 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84338-001-09 84338000109 88.7 mL in 1 BOTTLE, WITH APPLICATOR (84338-001-09) 88.7 ml 2004-12-02 No No Current 84338-001-16 84338000116 236 mL in 1 TUBE (84338-001-16) 236 ml 2004-12-02 No No Current 84338-001-23 84338000123 473.17 mL in 1 BOTTLE, PUMP (84338-001-23) 473.17 ml 2004-12-02 No No Current 84338-001-30 84338000130 59.14 mL in 1 TUBE (84338-001-30) 59.14 ml 2025-03-03 No No Current 84338-001-92 84338000192 118.29 mL in 1 TUBE (84338-001-92) 118.29 ml 2004-12-02 No No Current