Home NDC 0498-0021-40 Burn Water Soluble
Product NDC 0498-0021
Requested package NDC 0498-0021-40
11-digit product format 004980021
Labeler code 0498
Product ID 0498-0021_f0ec4b86-77a9-f36f-e053-2a95a90a660d
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Benzethonium chloride, Menthol
Dosage form SPRAY
Route TOPICAL
Labeler Honeywell Safety Products USA, Inc
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-11-12
Marketing end 0000-00-00
Substance BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL
Active strength 0 g/100g; g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZETHONIUM CHLORIDE ACTIVE INGREDIENT PH41D05744 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 BENZETHONIUM ACTIVE MOIETY 1VU15B70BP NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 BUTANE INACTIVE INGREDIENT 6LV4FOR43R NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 ISOBUTANE INACTIVE INGREDIENT BXR49TP611 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1 PROPANE INACTIVE INGREDIENT T75W9911L6 NORTH BURN (BENZOCAINE, BENZETHONIUM CHLORIDE, MENTHOL) SPRAY [NORTH SAFETY PRODUCTS] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0498-0021-40 00498002140 85 g in 1 CAN (0498-0021-40) 85 g 2018-11-12 0000-00-00 No No Current