FDA.reportPublic FDA data

Burn Relief

Product NDC
0498-0221
11-digit product format
004980221
Labeler code
0498
Product ID
0498-0221_f0eca06a-edfb-4513-e053-2995a90ac661
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Honeywell Safety Products USA, Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-18
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0498-0221DDiscontinued by firm2026-08-03
excluded packagepackage0498-02210498-0221-10DDiscontinued by firm2026-08-03
excluded packagepackage0498-02210498-0221-59DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0498-0221DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0498-02210498-0221-59DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0498-02210498-0221-10DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0498-0221DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0498-02210498-0221-59DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0498-02210498-0221-10DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0498-0221DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0498-02210498-0221-59DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0498-02210498-0221-10DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0498-0221DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0498-02210498-0221-59DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0498-02210498-0221-10DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0498-0221DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0498-02210498-0221-59DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0498-02210498-0221-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ANORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
LIDOCAINEACTIVE MOIETY98PI200987NORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4NORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RNORTH BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [NORTH SAFETY PRODUCTS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0498-0221-100049802211059 mL in 1 BOTTLE, SPRAY (0498-0221-10) 59 ml2018-09-180000-00-00NoNoCurrent
0498-0221-590049802215959 mL in 1 BOTTLE, SPRAY (0498-0221-59) 59 ml2018-09-180000-00-00NoNoCurrent