Home NDC 52412-300-10 Fire Out
Product NDC 52412-300
Requested package NDC 52412-300-10
11-digit product format 524120300
Labeler code 52412
Product ID 52412-300_a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and Menthol
Dosage form SOLUTION
Route TOPICAL
Labeler Randob Ltd.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-02-15
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 200; 10 mg/mL; mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 Fire Out
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/mL MENTHOL, UNSPECIFIED FORM 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1552282 Internal RxNorm lookup 1866401 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52412-300-10 Fire Out 1 in 1 CARTON SOLUTION 1 3 52412-300-10 Fire Out 50 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 50 3 52412-300-20 Fire Out 5 in 1 BLISTER PACK SOLUTION 5 3 52412-300-20 Fire Out 0.5 mL in 1 VIAL, SINGLE-USE SOLUTION 0.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-300 FIRE OUT (BENZOCAINE AND MENTHOL) SOLUTION [RANDOB LTD.] 3 Current NDC, Legacy NDC, 4 package rows 20190416_77ab634e-13d4-4f5f-87c8-73976e65a842.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52412-300-10 52412030010 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10) / 50 mL in 1 BOTTLE, WITH APPLICATOR 2016-02-15 0000-00-00 No No Current