FDA.reportPublic FDA data

AXIV Sinus Severe Ultra Fine Mist

Product NDC
82706-030
11-digit product format
827060030
Labeler code
82706
Product ID
82706-030_54f03226-1056-8325-e063-6394a90ac888
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride.
Dosage form
AEROSOL, SPRAY
Route
NASAL
Labeler
VIVUNT PHARMA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-19
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
AXIV Sinus Severe Ultra Fine Mist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b81abf9-3ea7-e996-e063-6394a90a71e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-030-01AXIV Sinus Severe Ultra Fine Mist15 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY152
82706-030-01AXIV Sinus Severe Ultra Fine Mist1 in 1 CARTONAEROSOL, SPRAY12

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 86 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
application number: M012
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.447951e6-459d-0a52-e063-6294a90a62262025-11-26WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
application number: M012
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
application number: M012
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
application number: M012
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
application number: M012
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
application number: M012
Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.96948973-09e3-4c05-8982-0494ebeaac4b2025-11-26WarningsExact identifier
application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
application number: M012
Walgreen CherryGUAIFENESINWALGREEN COMPANY1f1cb4a5-1ebd-483c-bf82-16931da00e052025-11-26WarningsExact identifier
application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
application number: M012
Walgreen Daytimel Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.452159e0-1204-460c-981f-cace4e815c6f2025-11-26WarningsExact identifier
application number: M012
Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWALGREEN CO.9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb2025-11-25WarningsExact identifier
application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRWALGREENS CO.c92a0f47-0b7c-4034-83d1-b7d2ed8022fc2025-11-25WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREENS CO.428081f5-b7eb-42da-963c-a587a44b2a792025-11-25WarningsExact identifier
application number: M012
Walgreen NightTime Cold and Flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENS CO.6b3766e6-d0d4-49e0-90da-fc893aef33292025-11-25WarningsExact identifier
application number: M012
Adult Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY586310f3-0014-4cfc-9d86-961b3fb7aa8c2025-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN4b81abf9-3ea7-e996-e063-6394a90a71e82
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4b81abf9-3ea7-e996-e063-6394a90a71e82
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY4b81abf9-3ea7-e996-e063-6394a90a71e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82706-030-01827060030011 BOTTLE, SPRAY in 1 CARTON (82706-030-01) / 15 mL in 1 BOTTLE, SPRAY2026-01-19NoNoCurrent