Home NDC 0498-0011 Pyrocaine Burn
Product NDC 0498-0011
11-digit product format 004980011
Labeler code 0498
Product ID 0498-0011_f0ec1312-bd4c-b7f0-e053-2995a90a84c5
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Benzethonium Chloride
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Honeywell Safety Products USA. Inc
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-01-01
Marketing end 0000-00-00
Substance BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength 0 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0498-0011-77 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0498-0011-77 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0498-0011-77 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0498-0011-77 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0498-0011-77 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0498-0011-77 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0498-0011-77 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0498-0011-77 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0498-0011-77 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0498-0011-77 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0498-0011-77 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0498-0011-77 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZETHONIUM CHLORIDE ACTIVE INGREDIENT PH41D05744 PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [NORTH SAFETY PRODUCTS] 1 BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [NORTH SAFETY PRODUCTS] 1 BENZETHONIUM ACTIVE MOIETY 1VU15B70BP PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [NORTH SAFETY PRODUCTS] 1 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [NORTH SAFETY PRODUCTS] 1 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, 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 0498-0011-77 00498001177 14.2 g in 1 CAN (0498-0011-77) 14.2 g 2018-01-01 0000-00-00 No No Current