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 14 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
application number: M012
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
application number: M012
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
application number: M012
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
application number: M012
DAY TIME NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.6372cbdd-a3a3-499d-91ce-53bcdb83e7392026-07-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacydf6e522c-3e30-4aa0-8ab9-3b579c80bcad2026-07-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC1c5386c1-e45d-9dcb-e063-6294a90aff072026-07-22WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact 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