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 8 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus PE Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Better Living Brands, LLC	28a4ec37-11dd-4134-81aa-851f081bf088	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	NASAL MIST	CVS PHARMACY,INC.	60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa	2026-08-17	Warnings	Exact identifier application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion Childrens	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreens	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2026-08-17	Warnings	Exact identifier application number: M012
CVS Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS HEALTH	f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6	2026-08-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	KROGER COMPANY	30d50bbe-0a14-c985-e063-6294a90a47b3	2026-08-16	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	77f87e19-a9d5-479d-9434-bbde13210bfb	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	b1c2055b-4b5a-4fa2-b600-8930c9c8524c	2026-08-15	Warnings	Exact identifier application number: M012
Nighttime HBP Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	146c9a62-0418-4b5d-9074-5be8a05f3f93	2026-08-15	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength, Non-Drowsy	PSEUDOEPHEDRINE HCL	Amerisource Bergen	1fdb1ba5-4072-4baf-9e30-f01d57bf6d82	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	32c67914-d7cf-40ee-8682-0ba8ed691287	2026-08-15	Warnings	Exact identifier application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	27820bce-6638-4f17-ac66-62b02b76bec3	2026-08-14	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE	CVS PHARMACY, INC.	004e104b-d6ff-48d5-8685-cd1bff45399a	2026-08-14	Warnings	Exact identifier application number: M012
CHILDRENS DIMETAPP COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	7babf4f6-ca0a-44a7-b1ea-d60e20d36f15	2026-08-14	Warnings	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	e7c8ffed-83b8-4088-b72c-d937e93f8b54	2026-08-14	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM and Overnight Cold and Flu	DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL	CVS	75520b77-d40b-4f43-b92a-7a3eba5b493f	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	bb24c298-1d00-4378-8de3-b4056220fa75	2026-08-14	Warnings	Exact identifier application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS Pharmacy,Inc.	6cb1d08b-e544-4084-b9ed-1e0d99a709c8	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: M012
Theraflu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	932a3d40-9b52-4e91-bc61-6fd506f2d9e6	2026-08-14	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy,Inc.	91063edd-1e7e-41e9-8412-b14ef3749018	2026-08-14	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