FDA.reportPublic FDA data

12 Hour Original Nasal Decongestant

Product NDC
11527-140
11-digit product format
115270140
Labeler code
11527
Product ID
11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142b
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal Spray
Dosage form
LIQUID
Route
NASAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
50 mg/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
12 Hour Original Nasal Decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE50 mg/100mL

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
cea0ce76-ae75-4484-a7c2-ff1086e9d8b0Available 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
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 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VY12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZY12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W712 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
DISODIUM EDTA-COPPERINACTIVE INGREDIENT6V475AX06U12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQ12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V312 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1
WATERINACTIVE INGREDIENT059QF0KO0R12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]1

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

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 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNcea0ce76-ae75-4484-a7c2-ff1086e9d8b05
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDcea0ce76-ae75-4484-a7c2-ff1086e9d8b05
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYcea0ce76-ae75-4484-a7c2-ff1086e9d8b05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11527-140-55115270140551 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY2014-05-300000-00-00NoNoCurrent