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 80 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Overnight Menthol Patch MENTHOL Veridian Healthcare 6379f50d-2878-46ca-8acb-71c4554585e9 2025-08-28 Warnings Exact identifier application number: M017 Anti Itch Maximum Relief PRAMOXINE HYDROCHLORIDE AND MENTHOL Natureplex LLC 75de3d5e-ecbe-4d04-a39d-792200e6ee32 2025-08-28 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 3d5718f3-c175-6b64-e063-6394a90aa6f1 2025-08-27 Warnings Exact identifier application number: M017 ARCTIC HEAT MENTHOL, METHYL SALICYLATE Renu Laboratories, LLC 402df5c1-b8cb-17a2-e054-00144ff8d46c 2025-08-27 Warnings Exact identifier application number: M017 PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE HYDROCORTISONE Click Industries LLC 328c389c-7e05-4892-a9b3-b6a753f4935a 2025-08-25 Warnings Exact identifier application number: M017 Yeheal CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL Shenzhen Yeheal Biotechnology Co., Ltd 3cf1bc74-3060-6d63-e063-6294a90a9f5c 2025-08-22 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Natures Formulae Health Products Ltd. 3ce29160-3964-e435-e063-6394a90abb38 2025-08-21 Warnings Exact identifier application number: M017 SUGARLOAF ORGANICS MENTHOL REVIVE MENTHOL RENU LABORATORIES, LLC fa2f9539-b703-a00b-e053-6394a90ae309 2025-08-21 Warnings Exact identifier application number: M017 Camphor 4% Plus Menthol 10% CAMPHOR 4% PLUS MENTHOL 10% PureTek Corporation 3cab26e4-e377-f26a-e063-6394a90a17af 2025-08-20 Warnings Exact identifier application number: M017 Capsaicin 0.035% Cream CAPSAICIN 0.035% CREAM Puretekcorp 3cbc73b6-8c58-8f23-e063-6394a90a71a3 2025-08-20 Warnings Exact identifier application number: M017 Game On MENTHOL, METHYL SALICYLATE Natural Essentials, Inc. 3cd20f1f-033f-f698-e063-6294a90a89eb 2025-08-20 Warnings Exact identifier application number: M017 ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 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