FDA.reportPublic FDA data

Vapor Inhaler

Product NDC
0363-0564
11-digit product format
003630564
Labeler code
0363
Product ID
0363-0564_33fde7b6-63bd-4fee-9bf2-e03b77e2d9df
Type
HUMAN OTC DRUG
Nonproprietary name
Levmetamfetamine Nasal Decongestant
Dosage form
INHALANT
Route
NASAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-01
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
77924474-ccc7-497b-9168-91490bcfadfcAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-0564-502023-03-08Drug Facts
0363-0564-532023-03-08Drug Facts
0363-0564-502023-01-30Drug Facts
0363-0564-532023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0564-50EA - Each0363-0564512ea658-5505-4150-9328-e460d31c080112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0564VAPOR INHALER (LEVMETAMFETAMINE NASAL DECONGESTANT) INHALANT [WALGREENS ]4Current NDC, Legacy NDC20241225_77924474-ccc7-497b-9168-91490bcfadfc.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 102 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
application number: M012
McKesson Sugar Free Cough Suppressant Oral AnestheticMENTHOL LOZENGEMcKesson Medical-Surgicale0dfa6ca-b311-25cb-e053-2a95a90a12cc2025-09-09WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
application number: M012
Medi-First Honey Lemon Cough DropsMENTHOL 8.6 MGUnifirst First Aid Corporation826e1b87-e5a9-8637-e053-2991aa0aded12025-09-09WarningsExact identifier
application number: M012
Unishield Cherry CoughMENTHOLUnishieldb8297bc1-44b2-3de0-e053-2995a90ad01b2025-09-09WarningsExact identifier
application number: M012
McKesson Cough SupressantMENTHOLMcKesson Medical-Surgicaldb5e0490-2ed8-2d53-e053-2a95a90a98f52025-09-09WarningsExact identifier
application number: M012
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
application number: M012
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
application number: M012
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact identifier
application number: M012
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
application number: M012
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0564-50003630564501 INHALER in 1 BLISTER PACK (0363-0564-50) / 198 INHALANT in 1 INHALER1 inhaler2016-07-010000-00-00NoNoCurrent
0363-0564-53003630564533 INHALER in 1 BLISTER PACK (0363-0564-53) / 198 INHALANT in 1 INHALER3 inhaler2016-07-010000-00-00NoNoCurrent