FDA.reportPublic FDA data

Vapor Inhaler

Manufacturer
C.D.M.A., Inc. | Aphena Pharma Solutions MD, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:29

Label at a glance#

ProductVapor Inhaler
Active ingredientLevmetamfetamine
Label structure9 sections

Dosage and administration

the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine do not use more often than every 2 hours adults and children 12 years of age and over 2 inhalations in each nostril children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril children under 6 years of age ask a doctor children under 2 years of age do not use

Label contents#

Full prescribing information#

Active ingredient (per inhaler)

OTC - ACTIVE INGREDIENT SECTION

Levmetamfetamine 50 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Use

INDICATIONS & USAGE SECTION

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • temporary burning, stinging, sneezing, or increased nasal discharge may occur
  • use of this container by more than one person may spread infection

OTC - DO NOT USE SECTION

  • do not use for more than 7 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
  • do not use more often than every 2 hours
adults and children 12 years of age and over 2 inhalations in each nostril
children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril
children under 6 years of age ask a doctor
children under 2 years of age do not use

Other information

OTHER SAFETY INFORMATION

  • this inhaler is effective for a minimum of 3 months after first use
  • keep inhaler tightly closed
  • store at 59°-86° F (15°-30° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

Questions or comments?

OTC - QUESTIONS SECTION

800-935-2362

Principal Display Panel – 198 mg Blister Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63868-267-01

QC®

QUALITY
CHOICE

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine
Temporary Relief of
Nasal Congestion Due to
Colds,
Hay Fever
Upper Respiratory Allergies

NET WT 0.007 OZ (198 mg)

Principal Display Panel – 198 mg Blister Pack Label
Principal Display Panel – 198 mg Blister Pack Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-267-012023-02-15C16284748780-1ba0f9c33-2407-a910-e053-dadaa90a0b85Drug Facts
63868-267-012023-01-30C16284748780-1ba0f9c33-2407-a910-e053-dadaa90a0b85Drug Facts
63868-267-012021-03-23C16284748780-1ba0f9c33-2407-a910-e053-dadaa90a0b85Drug Facts
63868-267-012021-01-29C16284748780-1ba0f9c33-2407-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-267-01Vapor Inhaler198 in 1 INHALERINHALANT1985
63868-267-01Vapor Inhaler1 in 1 BLISTER PACKINHALANT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-267VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [C.D.M.A., INC.]5Current NDC, Legacy NDC, 2 package rows20241225_904b7e21-cce5-4b96-afc1-b36f532f98ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-267-01EA - Each63868-26768ea58f3-3843-4800-ad47-b309a3e0b7a812022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LEVMETAMFETAMINEACTIVE INGREDIENTY24T9BT2Q21
LEVMETAMFETAMINEACTIVE MOIETYY24T9BT2Q21
BORNYL ACETATEINACTIVE INGREDIENT213431586X1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-26763868-267-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LevmetamfetamineY24T9BT2Q2ACTIB
Bornyl acetate213431586XIACT
Camphor (Synthetic)5TJD82A1ETIACT
Lavender oilZBP1YXW0H8IACT
MentholL7T10EIP3AIACT
Methyl SalicylateLAV5U5022YIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii+route
2 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii+route
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
16 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
ndc (package): 63868-267-01
ndc (product): 63868-267
ndc11 (package): 63868026701
spl id: c6db3d62-fa26-4f92-a947-6b9e734f4397
spl set id: 904b7e21-cce5-4b96-afc1-b36f532f98ac

Reported adverse events (FAERS/openFDA)#

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