Lidocaine

Product NDC
56104-006
Requested package NDC
56104-006-45
11-digit product format
561040006
Labeler code
56104
Product ID
56104-006_c70445a1-59cb-9b30-e053-2a95a90a21c9
Type
HUMAN OTC DRUG
Nonproprietary name
Burn Relief Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
1 g/127g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage56104-00656104-006-45DDiscontinued by firm2026-10-16

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
BUTANEINACTIVE INGREDIENT6LV4FOR43RLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ELIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
DISODIUM COCOAMPHODIPROPIONATEINACTIVE INGREDIENT6K8PRP397MLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
PROPANEINACTIVE INGREDIENTT75W9911L6LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE (BURN RELIEF SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-006-4556104000645127 g in 1 CANISTER (56104-006-45) 127 g2013-01-010000-00-00NoNoCurrent