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 176 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC169006cb-7dc2-4113-a289-0b1f14e784b72023-10-23WarningsExact identifier
application number: M012
Night-Time Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealthLife of USA2ffd62a6-703f-4cb0-bb13-49719c004d002023-10-21WarningsExact identifier
application number: M012
Day-Time Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHANHealthLife of USAc5f6cf22-2aaa-40e1-b7b3-448e55898d622023-10-21WarningsExact identifier
application number: M012
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
application number: M012
Day and Night Multi Symptom Cold and Flu ReliefDAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEFIntrivo Diagnostics Inc.a311bf39-de6c-4ed5-949e-718ad8be1e492023-10-13WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0d65c4a9-938c-4a89-b1f1-d9ada8a8c5872023-10-10WarningsExact identifier
application number: M012
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreensa33ae35b-1cde-4a3d-a836-3b169e4f1bb92023-10-10WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
application number: M012
Cold and Congestion Childrens NighttimeDIPHENHYDRAMINE HCI, PHENYLEPHRINE HCLWalgreensa7847413-e556-4f88-8a7f-a8528afbe9272023-10-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLC06d2c6cf-0adb-91b9-e063-6294a90aff522023-10-03WarningsExact identifier
application number: M012
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
application number: M012
Maximum strength Day cold and flu and Night severe cold and fluACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETSTIME CAP LABORATORIES,INCfff69901-965c-5372-e053-6394a90a29c22023-09-18WarningsExact 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