FDA.reportPublic FDA data

Rhinase Lubricating Nasal Mist

Manufacturer
Profounda Inc
Effective date
2019-05-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:26

Label at a glance#

ProductRhinase Lubricating Nasal Mist
Label structure8 sections

Dosage and administration

One or two sprays into each nostril every four hours or as needed

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Carbopol, Benzalkonium Chloride, Sodium Phosphate Dibasic, Potassium Phosphate monobasic

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

ACtive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol

Potassium Chloride

Propylene Glycol

Sodium Chloride

Directions

DOSAGE & ADMINISTRATION SECTION

One or two sprays into each nostril every four hours or as needed

Indication and usage

INDICATIONS & USAGE SECTION

Relieves dryness and irritation to and around the nose (nasal passages) caused by: dry room air, allergies,low humidity, chronic sinusitis, nose bleeds, stuffy nose, cold/flu, winter dryness, CPAP / BiPAP, travel, Oxygen therapy.

Adds moisture inside the nose to dissolve and soften thick, crusty mucus, making it easier to remove.

Purpose

OTC - PURPOSE SECTION

Moisturizer / Wetting Agent

Warnings

WARNINGS SECTION

- Use only as directed - Keep this and all drugs out of reach of children - The use of this dispensor by more than one person may spread infection

Rhonase Lubricating Nasal Mist

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RHINASE LUBRICATING NASAL MISTRHINASE LUBRICATING NASAL MIST

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69051-200-012021-01-29C16284748780-1ba0f9c33-4557-a910-e053-dadaa90a0b85Rhinase Lubricating Nasal Mist

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69051-200-01Rhinase Lubricating Nasal Mist30 g in 1 CARTONSPRAY, METERED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69051-200RHINASE LUBRICATING NASAL MIST (POLYETHYLENE GLYCOL POTASSIUM CHLORIDE, PROPYLENE GLYCOL, SODIUM CHLORIDE) SPRAY, METERED [PROFOUNDA INC]31 package rows20190509_2dcbd1f2-da50-517a-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69051-200-01ML - Milliliter69051-20002d74c6b-a28e-4ffc-873c-58a58426ed3512017-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69051-20069051-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATEBWZ7K44R51INGR
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51INGR
POLYETHYLENE GLYCOL 3350G2M7P15E5PINGR
DIPROPYLENE GLYCOLE107L85C40INGR
SODIUM CHLORIDE451W47IQ8XINGR
POTASSIUM CHLORIDE660YQ98I10INGR
WATER059QF0KO0RINGR
BENZALKONIUM CHLORIDEF5UM2KM3W7INGR

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
88742f09-dd8a-e62f-e053-2a95a90a67b12dcbd1f2-da50-517a-e054-00144ff8d46c2019-05-09WarningsExact identifier
spl id: 88742f09-dd8a-e62f-e053-2a95a90a67b1
spl set id: 2dcbd1f2-da50-517a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.