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 18 of 153 · 3,057 matching rows.
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