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

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: 12 Hour Original Nasal Decongestant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	50 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11527-140-55	2021-03-17	C162847	48780-1	ba0f9c33-5d78-a910-e053-dadaa90a0b85	Sheffield 12HR Nasal Spray
11527-140-55	2021-01-29	C162847	48780-1	ba0f9c33-5d78-a910-e053-dadaa90a0b85	Sheffield 12HR Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11527-140-55	12 Hour Original Nasal Decongestant	1 in 1 CARTON	LIQUID	1		5
11527-140-55	12 Hour Original Nasal Decongestant	30 mL in 1 BOTTLE, SPRAY	LIQUID	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11527-140-55	ML - Milliliter	11527-140	82b4bf48-041a-4d80-89ab-bdf904601d87	1	2025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
DISODIUM EDTA-COPPER	INACTIVE INGREDIENT	6V475AX06U	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-140	12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [SHEFFIELD PHARMACEUTICALS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20231031_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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Exact identifier application number: M012
Cough and Runny Nose Childrens Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	TOP CARE (Topco Associates LLC)	6f04bd51-093c-4624-aef3-0145ac387386	2026-06-01	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	694a3116-1b75-42cd-bbcf-d19831c2d796	2026-06-01	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	cf31538c-9eee-4c81-80cb-66eecabf0aff	2026-06-01	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	155e07b3-0a08-3be8-e063-6394a90a7635	2026-05-31	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Nighttime	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	156033ae-b16a-007b-e063-6294a90a7445	2026-05-31	Warnings	Exact identifier application number: M012
Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	ebf8c82d-a653-4c02-893b-61704901acbb	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Amerisource Bergen	934c7b91-3cba-47f0-8efa-77216f3f15c4	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Medicine	DIPHENHYDRAMINE HCL	COSTCO WHOLESALE CORPORATION	d9f03e11-d11f-43ee-8ed0-9e07d1058f66	2026-05-29	Warnings	Exact identifier application number: M012
Cold Childrens, Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d	2026-05-29	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	3598ac5b-29f9-f002-e063-6294a90a62cb	2026-05-28	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2026-05-28	Warnings	Exact identifier application number: M012
Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	a7ab2140-de09-158f-e053-2a95a90a25a0	2026-05-28	Warnings	Exact identifier application number: M012
Kids Multi Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	2d918ec8-3098-1d09-e063-6294a90a9e8f	2026-05-28	Warnings	Exact identifier application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Genexa Inc.	213fe898-dace-9a0f-e063-6394a90afd64	2026-05-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Lemon Flavor	MENTHOL	Medical Group Care LLC	556628ab-e233-92fe-e063-6394a90a0090	2026-05-28	Warnings	Exact identifier application number: M012
Sinus Decongestion PE	PHENYLEPHRINE HCL	Kroger Company	68eff734-177e-4999-9126-6b92bb204107	2026-05-28	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	ARMY AND AIR FORCE EXCHANGE SERVICE	ff39084f-ab2f-48ed-ac62-837f7fff2b65	2026-05-28	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Select Consumer Group LLC	52c5fda0-c358-72e8-e063-6394a90a3f68	2026-05-27	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	16637d54-8049-d3ce-e063-6394a90aafc9	2026-05-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	5
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	5
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-140-55	11527014055	1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY	2014-05-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sheffield 12HR Nasal Spray	Sheffield Pharmaceuticals LLC	2023-10-30	HUMAN OTC DRUG LABEL	5
Dr. Sheffield's Original 12 Hour Relief Nasal Spray	Navajo Manufacturing Company Inc. \| Sheffield Pharmaceuticals LLC	2020-12-10	HUMAN OTC DRUG LABEL	1
Nasal Spray - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2020-07-30	HUMAN OTC DRUG LABEL	3