Indications and uses
for temporary relief of nasal congestion due to a cold due to hay fever or other upper respiratory allergies shrinks swollen membranes so you can breathe more freely
Privine ® nasal spray
- Manufacturer
- Insight Pharmaceuticals
- Effective date
- 2009-07-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:22:33
Label at a glance#
ProductPrivine
Active ingredientNaphazoline Hydrochloride
Label structure12 sections
Dosage and administration
adults and children 12 years of age and over: 1 or 2 sprays in each nostril not more often than every 6 hours. children under 12 years of age: consult a doctor.
Storage and handling
store at room temperature 20°–25°C (68°–77°F).
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (per spray)
Naphazoline HCl, USP 0.05%
Purpose
Nasal decongestant
Uses
for temporary relief of nasal congestion
- due to a cold
- due to hay fever or other upper respiratory allergies
- shrinks swollen membranes so you can breathe more freely
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product
- do not exceed recommended dosage
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
- use only as directed
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist
The use of this container by more than one person may spread infection
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: 1 or 2 sprays in each nostril not more often than every 6 hours.
- children under 12 years of age: consult a doctor.
Other information
store at room temperature 20°–25°C (68°–77°F).
Inactive Ingredients
benzalkonium chloride, dibasic sodium phosphate, disodium edetate, monobasic sodium phosphate, purified water and sodium chloride.
Questions
Call 1-800-344-7239 or write to Consumer Affairs.
SPL UNCLASSIFIED SECTION
Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749
PRINCIPAL DISPLAY PANEL - 20 mL spray label
69853C
LF-572
FAST RELIEF
OF STUFFY NOSE
Privine®
nasal spray
naphazoline HCl, USP
Nasal Decongestant
Do not use if the plastic band on the
bottle cap is missing or damaged.
Store between 20°–25°C (68°–77°F).
0.66 fl oz (20 mL)
PRINCIPAL DISPLAY PANEL - 20 mL spray carton
Fast
relief
of
stuffy
nose
Privine®
nasal spray
naphazoline HCl, USP
Nasal Decongestant
Important:
Do not use if
the plastic band
on the bottle
cap is missing
or damaged.
0.66 fl oz (20mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046610 | naphazoline HCl 0.05 % Nasal Spray | PSN | 1 |
| 1046611 | Privine 0.05 % Nasal Spray | PSN | 1 |
| 1046611 | naphazoline hydrochloride 0.5 MG/ML Nasal Spray [Privine] | SBD | 1 |
| 1046610 | naphazoline hydrochloride 0.5 MG/ML Nasal Spray | SCD | 1 |
| 1046610 | naphazoline HCl 0.05 % Nasal Spray | SY | 1 |
| 1046611 | Privine 0.05 % Nasal Spray | SY | 1 |
| 1046611 | Privine 0.5 MG/ML Nasal Spray | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e18001c8-33ae-5f66-9cdc-a39724bd4573 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63736-662-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-dfa7-621f-e053-dbdaa90a74ad | Privine ® nasal spray |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63736-662-02 | Privine | 1 in 1 BOX | SPRAY | 1 | 1 | |
| 63736-662-02 | Privine | 20 mL in 1 BOTTLE | SPRAY | 20 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Naphazoline Hydrochloride | ACTIVE INGREDIENT | MZ1131787D | 1 | |
| Naphazoline | ACTIVE MOIETY | H231GF11BV | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | 1 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Privine
- Naphazoline Hydrochloride
- Naphazoline
- benzalkonium chloride
- sodium phosphate, dibasic
- edetate disodium
- sodium phosphate, monobasic
- water
- sodium chloride
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63736-662 | 63736-662-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Naphazoline Hydrochloride | MZ1131787D | ACTIM |
| benzalkonium chloride | F5UM2KM3W7 | IACT |
| sodium phosphate, dibasic | GR686LBA74 | IACT |
| edetate disodium | 7FLD91C86K | IACT |
| sodium phosphate, monobasic | 3980JIH2SW | IACT |
| water | 059QF0KO0R | IACT |
| sodium chloride | 451W47IQ8X | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | SUSPENSION / OPHTHALMIC | 0.43 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOAP / TOPICAL | 1.26 %w/w | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | CONCENTRATE / ORAL | 17 mg/5ml | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 40 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2922 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRABURSAL | 9 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / AURICULAR (OTIC) | 18 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAMUSCULAR | 17 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | GEL / OPHTHALMIC | 0.01 %w/w | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION / INTRAVENOUS | 161 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRA-ARTICULAR | 26 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / DENTAL | 0.4 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INFILTRATION | 3535 mg | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | INJECTION / INTRAVENOUS | 200 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | SYSTEM / TOPICAL | 14.2 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LOTION / TOPICAL | 0.1 %w/w | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | OINTMENT / TOPICAL | 0.03 %w/w | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | POWDER / RESPIRATORY (INHALATION) | NA | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVASCULAR | NA | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | CLOTH / TOPICAL | NA | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / EPIDURAL | 648 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / OPHTHALMIC | 2 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | 1.35 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / OPHTHALMIC | 0.06 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2584355b-c068-4bca-87f6-7854da08610b | ec2bb7d7-d014-46ed-a836-453e921da4c5 | 2009-07-31 | Warnings | 2584355b-c068-4bca-87f6-7854da08610b ec2bb7d7-d014-46ed-a836-453e921da4c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.