FDA.reportPublic FDA data

Sheffield 12HR Nasal Spray

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:58:27

Label at a glance#

Product12 Hour Original Nasal Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Tempoarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiroty allergies Shribnk swollen membranes so you can breathemore freely

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiroty allergies
  • Shribnk swollen membranes so you can breathemore freely

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

When using this product

OTC - WHEN USING SECTION

  • Do not use more than directed
  • do not use for more than three days, Use onyl as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning ,stinging, sneezing or an increase in nasal discharge may occur.
  • use of this container by more thna one person may spread infection.

stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist.

PREGNANCY SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal display panel- Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceutical          NDC 11527-140-55

Original Nasal Spray 

Oxymetazoline HCL 0.05%

12hour relief of Nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies

30 mL  (1.01 FL OZ)

Nasal Spray Front label bottle 1 OZNasal Spray Front label bottle 1 OZ

Principal display panel- Bottle back label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panel- Bottle back labelPrincipal display panel- Bottle back label

Principal display panel- Bottle back labelPrincipal display panel- Bottle back label

Nasal Spray Front label bottle 1 OZNasal Spray Front label bottle 1 OZ

Principal display panel -Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals                           NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12 hour relief of Nasal congestion due to:

  • common cold
  • hay fever
  • sinusititus 
  • upper respiratory allerigies

30 mL (1.01 FL OZ)

Principal display panel -CartonPrincipal display panel -Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN5
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD5
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11527-140-552021-03-17C16284748780-1ba0f9c33-5d78-a910-e053-dadaa90a0b85Sheffield 12HR Nasal Spray
11527-140-552021-01-29C16284748780-1ba0f9c33-5d78-a910-e053-dadaa90a0b85Sheffield 12HR Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-140-5512 Hour Original Nasal Decongestant1 in 1 CARTONLIQUID15
11527-140-5512 Hour Original Nasal Decongestant30 mL in 1 BOTTLE, SPRAYLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-14012 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [SHEFFIELD PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20231031_cea0ce76-ae75-4484-a7c2-ff1086e9d8b0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-140-55ML - Milliliter11527-14082b4bf48-041a-4d80-89ab-bdf904601d8712025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VY1
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZY1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
DISODIUM EDTA-COPPERINACTIVE INGREDIENT6V475AX06U1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQ1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-14011527-140-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POVIDONE K29/32390RMW2PEQIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / TOPICAL14.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / TOPICAL14.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+dosage form
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii+route
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / NASAL5 mgExact identifier — unii+route
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii+route
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii+route
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / NASAL5 mgExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+dosage form
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+route
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQLIQUID / INTRAVENOUS5850 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii+route
8 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQLIQUID / INTRAVENOUS5850 mgExact identifier — unii+dosage form
2 equally ranked IID candidates

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
12 Hour Original Nasal DecongestantNASAL SPRAYSheffield Pharmaceuticals LLCcea0ce76-ae75-4484-a7c2-ff1086e9d8b02023-10-30WarningsExact identifier
ndc (package): 11527-140-55
ndc (product): 11527-140
ndc11 (package): 11527014055
spl id: 36eb3a35-be6c-4e5f-a189-2575f5dd142b
spl set id: cea0ce76-ae75-4484-a7c2-ff1086e9d8b0

Reported adverse events (FAERS/openFDA)#

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