FDA.reportPublic FDA data

Lanacane First Aid

Product NDC
63824-820
Requested package NDC
63824-820-35
11-digit product format
638240820
Labeler code
63824
Product ID
63824-820_829224e0-c8d6-4a86-8791-6aecaedc0348
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium chloride and Benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-06-19
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength
2 mg/g; mg/g
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

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 packagepackage63824-82063824-820-35DDiscontinued by firm2026-10-15

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 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-11-29Lanacane ® First Aid Spray
2023-07-28Lanacane ® First Aid Spray
2022-01-30Lanacane ® First Aid Spray
2022-01-28Lanacane ® First Aid Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-820-35GM - Gram63824-8205568c8e1-8bac-47f3-8291-4d8ae22ae69812014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzethonium chlorideACTIVE INGREDIENTPH41D05744LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
BenzocaineACTIVE INGREDIENTU3RSY48JW5LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
BenzethoniumACTIVE MOIETY1VU15B70BPLANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
BenzocaineACTIVE MOIETYU3RSY48JW5LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MLANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
ALOEINACTIVE INGREDIENTV5VD430YW9LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZLANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611LANACANE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [RECKITT BENCKISER LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-820-356382408203599 g in 1 CAN (63824-820-35) 99 g2012-06-190000-00-00NoNoCurrent