fire out

Generic: benzocaine and menthol

Labeler: randob ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name fire out
Generic Name benzocaine and menthol
Labeler randob ltd.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/mL, menthol, unspecified form 10 mg/mL

Manufacturer
Randob Ltd.

Identifiers & Regulatory

Product NDC 52412-300
Product ID 52412-300_a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part348
Listing Expiration 2026-12-31
Marketing Start 2016-02-15

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52412300
Hyphenated Format 52412-300

Supplemental Identifiers

RxCUI
1552282 1866401
UNII
U3RSY48JW5 L7T10EIP3A
NUI
N0000185508 N0000175629 N0000184306 M0000728

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 fire out (source: ndc)
Generic Name benzocaine and menthol (source: ndc)
Application Number part348 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10) / 50 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

52412-300-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10) / 50 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (2)

benzocaine (200 mg/mL) menthol, unspecified form (10 mg/mL)

Linked Drug Pages (1)

Fire Out ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "L7T10EIP3A"], "rxcui": ["1552282", "1866401"], "spl_set_id": ["77ab634e-13d4-4f5f-87c8-73976e65a842"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Randob Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10)  / 50 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "52412-300-10", "marketing_start_date": "20160215"}], "brand_name": "Fire Out", "product_id": "52412-300_a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a", "dosage_form": "SOLUTION", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "52412-300", "generic_name": "Benzocaine and Menthol", "labeler_name": "Randob Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fire Out", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/mL"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "10 mg/mL"}], "application_number": "part348", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20160215", "listing_expiration_date": "20261231"}