Home NDC 70983-027 Extra Strength Balm
Product NDC 70983-027
11-digit product format 709830027
Labeler code 70983
Product ID 70983-027_484f4f3a-5682-ca7d-e063-6394a90a982c
Type HUMAN OTC DRUG
Nonproprietary name Capsicum and Menthol
Dosage form OINTMENT
Route TOPICAL
Labeler Saje Natural Business Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-18
Substance MENTHOL; CAPSICUM
Active strength 2258.75; 5000 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 Extra Strength Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2258.75 mg/g CAPSICUM 5000 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 00UK7646FG 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 70983-027-01 Extra Strength Balm 1 in 1 BOX OINTMENT 1 4 70983-027-01 Extra Strength Balm 25 g in 1 JAR OINTMENT 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-027 EXTRA STRENGTH BALM (CAPSICUM AND MENTHOL) OINTMENT [SAJE NATURAL BUSINESS INC] 3 Current NDC, 2 package rows 20231006_f516e416-446b-8f21-e053-2a95a90afd88.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 122 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join anti itch HYDROCORTISONE Meijer, Inc. 2db7bcab-acb8-48ad-8cd1-842ff7765ed9 2024-10-23 Warnings Exact identifier application number: M017 NATUREANCE MIRACLE MENTHOL EROS GLOBAL CORP ec1a2a1f-a38d-9c59-e053-2a95a90ad268 2024-10-23 Warnings Exact identifier application number: M017 Profoot Plantar Relief Strips CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. 65e142d8-da21-4c55-9faf-b387cb6c2c0e 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. cc011b79-2761-40f7-8142-88f8e30a179a 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Profoot, Inc. 06f82bde-41a1-35f6-e063-6394a90a6437 2024-10-23 Warnings Exact identifier application number: M017 Deep Cover Bug Bite Relief BENZOCAINE Morrisons Outdoors, LLC 25010dd6-fb48-8ee7-e063-6394a90aee6c 2024-10-21 Warnings Exact identifier application number: M017 Evel Knievels Natural Choice Pain Relief MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 4576656c-4b6e-6965-7665-6c52756c6573 2024-10-21 Warnings Exact identifier application number: M017 berkley and jensen anti itch HYDROCORTISONE BJWC 5cc6e4f6-c62d-4923-9726-9dbc569a3f49 2024-10-19 Warnings Exact identifier application number: M017 DG Health Hydrocortisone Maximum Strength HYDROCORTISONE Dolgencorp Inc 2cc792b8-dce6-4178-bd6d-63ba268b7747 2024-10-19 Warnings Exact identifier application number: M017 Careland Hydrogel Pain Relief Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. e970070c-1c3b-49f0-8298-e6c5ebbf50a0 2024-10-18 Warnings Exact identifier application number: M017 Fruit of the Earth Cool Blue Aloe Mist Continuous LIDOCAINE HYDROCHLORIDE Fruit Of The Earth, Inc. d4caae4c-efba-2453-e053-2995a90a5e5f 2024-10-18 Warnings Exact identifier application number: M017 CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving LIDOCAINE HCL CVS Pharmacy f0f1969d-10e0-76ee-e053-2995a90a7336 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wong To Yick Wood Lock Ointment Ltd 16a21af4-6bc0-4ae1-aa3b-1da84c8286e2 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wicsun Trading Inc 0b4bd444-b3c1-47aa-a7e3-f16c92326124 2024-10-17 Warnings Exact identifier application number: M017 Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL LIDOCAINE Fruit of the Earth, Inc. c7a833bd-7457-73a3-e053-2a95a90ac53f 2024-10-17 Warnings Exact identifier application number: M017 Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic LIDOCAINE HYDROCHLORIDE WEGMANS FOOD MARKETS INC f70bc438-7ed8-f74d-e053-6394a90a2b3f 2024-10-16 Warnings Exact identifier application number: M017 EQUATE Sunburn relief with Aloe After Sun LIDOCAINE Wal-Mart Stores Inc c25e1288-7ac6-41fc-ab65-26c379f288a7 2024-10-16 Warnings Exact identifier application number: M017 Genuine First Aid Insect Sting Relief Pad 1 ct BENZOCAINE, ALCOHOL GFA Production (Xiamen) Co., Ltd. b119ba37-0ee1-851a-e053-2995a90a85b1 2024-10-15 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 1a587e6e-88d1-4b01-abad-9a365dc64a4d 2024-10-15 Warnings Exact identifier application number: M017 TopCare Everyday After Sun Cooling LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES LLC baff7293-e1a3-d1f2-e053-2995a90a93ca 2024-10-15 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 70983-027-01 70983002701 1 JAR in 1 BOX (70983-027-01) / 25 g in 1 JAR 1 jar 2023-02-24 No No Current