extra strength balm

Generic: capsicum and menthol

Labeler: saje natural business inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name extra strength balm
Generic Name capsicum and menthol
Labeler saje natural business inc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

capsicum 5000 mg/g, menthol 2258.75 mg/g

Manufacturer
Saje Natural Business Inc

Identifiers & Regulatory

Product NDC 70983-027
Product ID 70983-027_484f4f3a-5682-ca7d-e063-6394a90a982c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2023-02-18

Pharmacologic Class

Established (EPC)
non-standardized plant allergenic extract [epc] non-standardized food allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs] vegetable proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70983027
Hyphenated Format 70983-027

Supplemental Identifiers

UNII
00UK7646FG L7T10EIP3A
NUI
N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name extra strength balm (source: ndc)
Generic Name capsicum and menthol (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5000 mg/g
  • 2258.75 mg/g
source: ndc
Packaging
  • 1 JAR in 1 BOX (70983-027-01) / 25 g in 1 JAR
source: ndc

Packages (1)

70983-027-01 1 JAR in 1 BOX (70983-027-01) / 25 g in 1 JAR

Ingredients (2)

capsicum (5000 mg/g) menthol (2258.75 mg/g)

Linked Drug Pages (1)

Extra Strength Balm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "484f4f3a-5682-ca7d-e063-6394a90a982c", "openfda": {"nui": ["N0000185375", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0022575"], "unii": ["00UK7646FG", "L7T10EIP3A"], "spl_set_id": ["f516e416-446b-8f21-e053-2a95a90afd88"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Vegetable Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]"], "manufacturer_name": ["Saje Natural Business Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 JAR in 1 BOX (70983-027-01)  / 25 g in 1 JAR", "package_ndc": "70983-027-01", "marketing_start_date": "20230224"}], "brand_name": "Extra Strength Balm", "product_id": "70983-027_484f4f3a-5682-ca7d-e063-6394a90a982c", "dosage_form": "OINTMENT", "pharm_class": ["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]"], "product_ndc": "70983-027", "generic_name": "Capsicum and Menthol", "labeler_name": "Saje Natural Business Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Extra Strength Balm", "active_ingredients": [{"name": "CAPSICUM", "strength": "5000 mg/g"}, {"name": "MENTHOL", "strength": "2258.75 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230218", "listing_expiration_date": "20271231"}