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 107 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTIDOGESIC	DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN	ACTIPHARMA, LLC	697da3f9-9888-4d41-ba83-87ca9bf1e54b	2025-08-18	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rite Aid Corporation	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	2025-08-18	Warnings	Exact identifier application number: M012
MAJOR NASAL DECONGESTANT	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	4b78b9af-0975-43f8-8b44-daddef0478be	2025-08-15	Warnings	Exact identifier application number: M012
Dr Simi Mucus Relief Expectorant	GUAIFENESIN	Farmacias De Similares TX LLC	3c6d0e75-a685-6020-e063-6294a90a5c1b	2025-08-15	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	25bf4390-23f7-4bb6-b86e-c40eaf8d92da	2025-08-15	Warnings	Exact identifier application number: M012
Childrens Chewable Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2cac72be-4830-ad49-e063-6394a90a7832	2025-08-14	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AMERISOURCE BERGEN	2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e	2025-08-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walmart Inc.	16fae164-28db-8ef1-e063-6294a90ab5da	2025-08-12	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	fbece335-a7e5-4732-a086-561b23741579	2025-08-12	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	779ddb89-b6e2-4bfb-bcb5-8c7ec916675a	2025-08-12	Warnings	Exact identifier application number: M012
Equaline Nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	d7fa1720-eac4-4e82-9401-77215ce4f545	2025-08-12	Warnings	Exact identifier application number: M012
Diabetic Tussin DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	MEDTECH PRODUCTS INC	a10a3b33-7503-4334-8ed7-2bb881df4327	2025-08-08	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Exact identifier application number: M012
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	2025-08-06	Warnings	Exact identifier application number: M012
childrens cold cough dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Publix Super Markets Inc	6efe7097-2a99-4654-9d94-b47f2e64d19d	2025-08-05	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Chain Drug Marketing Association, Inc.	3b7548ee-7cd3-62c3-e063-6294a90a0612	2025-08-03	Warnings	Exact identifier application number: M012
Vaporizing chest rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	LJ Pharma	065bb666-e482-4e96-ac75-c6577dcc5b48	2025-08-01	Warnings	Exact identifier application number: M012
Nighttime Cough-Kids	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Genexa	024bb864-4214-1d8b-e063-6394a90aa573	2025-08-01	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Pharmadel LLC	3b53e5fc-f258-c2b9-e063-6394a90ab500	2025-08-01	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