FDA.reportPublic FDA data

Vapor Inhaler

Product NDC
63868-267
11-digit product format
638680267
Labeler code
63868
Product ID
63868-267_c6db3d62-fa26-4f92-a947-6b9e734f4397
Type
HUMAN OTC DRUG
Nonproprietary name
Levmetamfetamine Nasal Decongestant
Dosage form
INHALANT
Route
NASAL
Labeler
C.D.M.A., Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
LEVMETAMFETAMINE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Vapor Inhaler
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVMETAMFETAMINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y24T9BT2Q2Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904b7e21-cce5-4b96-afc1-b36f532f98acAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-15Drug Facts
2023-01-30Drug Facts
2021-03-23Drug Facts
2021-01-29Drug 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 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVMETAMFETAMINEACTIVE INGREDIENTY24T9BT2Q2VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
LEVMETAMFETAMINEACTIVE MOIETYY24T9BT2Q2VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
BORNYL ACETATEINACTIVE INGREDIENT213431586XVAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETVAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AVAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YVAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1

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

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 45 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS Pharmacy48438525-e49f-9303-e063-6394a90a44f22026-03-16WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nighttime SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy4981bbcd-7178-335f-e063-6394a90ae9612026-03-16WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-267-01638680267011 INHALER in 1 BLISTER PACK (63868-267-01) / 198 INHALANT in 1 INHALER1 inhaler2014-01-010000-00-00NoNoCurrent