FDA.reportPublic FDA data

Vapor Inhaler

Product NDC
50804-281
11-digit product format
508040281
Labeler code
50804
Product ID
50804-281_b8281bf5-7622-4746-9ca4-611ffad1d01d
Type
HUMAN OTC DRUG
Nonproprietary name
Levmetamfetamine
Dosage form
INHALANT
Route
NASAL
Labeler
Geiss, Destin & Dunn, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-08
Marketing end
0000-00-00
Substance
LEVMETAMFETAMINE
Active strength
50 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50804-281DDiscontinued by firm2026-10-05
excluded packagepackage50804-28150804-281-07DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-281-072023-02-13C16284748780-1f386c64a-2a7a-0266-e053-dadaa90a7c1aDrug Facts
50804-281-072023-01-30C16284748780-1f386c64a-2a7a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-281-07Vapor Inhaler levmetamfetamine nasal decongestant, Good Sense198 in 1 INHALERINHALANT1984
50804-281-07Vapor Inhaler levmetamfetamine nasal decongestant, Good Sense1 in 1 BLISTER PACKINHALANT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-281-07EA - Each50804-281a2c3d155-ac73-488c-b5f7-1fd49140574a12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-281VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, GOOD SENSE (LEVMETAMFETAMINE) INHALANT [GEISS, DESTIN & DUNN, INC.]3Legacy NDC, 2 package rows20241225_69059828-25dc-444f-bab4-0ec5325e5b91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-281-07508040281071 INHALER in 1 BLISTER PACK (50804-281-07) > 198 INHALANT in 1 INHALER1 inhaler2021-03-080000-00-00NoNoCurrent