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 159 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare childrens allergyDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC6b784cde-3152-4421-a825-dd1fc601aa7a2024-07-17WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
application number: M012
basic care allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC7d237d37-21c7-476d-a8b7-d91ea1b472ee2024-07-16WarningsExact identifier
application number: M012
Berkley and Jensen Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWCb52fc311-8853-4116-941b-8be35456abba2024-07-16WarningsExact identifier
application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreens0b9a4438-7d13-484c-a614-2dedc24974dc2024-07-16WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEPublix Super Markets Inc23a98385-28cc-4fac-8c87-b3ced81065322024-07-16WarningsExact identifier
application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe0.05% OXYMETAZOLINEWalgreens Companyaad01028-cbe0-4c10-adbc-d157bfa5af092024-07-16WarningsExact identifier
application number: M012
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
application number: M012
Maximum Strength Cold TabsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEJHK DBA American Safety & First Aide7d4fe9a-eb09-4266-90c9-290f61ce6ad02024-07-15WarningsExact identifier
application number: M012
ACTIDOM DACHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC7797c22e-ffeb-4798-9fb6-aa64cf077ba72024-07-15WarningsExact identifier
application number: M012
Nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1cf3064d-4ddd-63b9-e063-6294a90aa5472024-07-11WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLTARGET CORPORATION1ccbdb53-3f70-28da-e063-6394a90a9ae02024-07-09WarningsExact identifier
application number: M012
AXIV Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1cd2a6f1-31ad-e507-e063-6394a90aba582024-07-09WarningsExact identifier
application number: M012
Poly Hist ForteDOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aa0015b-8fc1-7951-e053-2a95a90a8e722024-07-09WarningsExact identifier
application number: M012
DECONEX DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aab8e5c-1633-2e5a-e053-2a95a90adcc52024-07-09WarningsExact identifier
application number: M012
Deconex IRGUAIFENESIN AND PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.4710095e-3dae-4a39-8a98-873012e1f0032024-07-09WarningsExact identifier
application number: M012
Diabetic Tussin Sore Throat and Cough CherryBENZOCAINE AND DEXTROMETHORPHAN HBRMEDTECH PRODUCTS INCe9327079-e0fc-4c95-b1d5-bc1b74870c9b2024-07-09WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporationfac859a4-e23a-4879-af6c-26368455506d2024-07-05WarningsExact identifier
application number: M012
Severe Throat DropsMENTHOL ICETarget Corporation Inc.1876b221-fa60-5269-e063-6394a90a69632024-07-04WarningsExact 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