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 121 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	f40bfdfc-1cb4-4604-9790-fb8d1d5173c6	2025-01-31	Warnings	Exact identifier application number: M012
NIGHTIME COLD AND FLU	NIGHTIME COLD AND FLU	TARGET CORP	9dee9b92-eac9-b07d-e053-2995a90a0602	2025-01-31	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Bryant Ranch Prepack	7b23faa9-40c8-4cea-b9fb-487cce2664af	2025-01-31	Warnings	Exact identifier application number: M012
BENADRYL Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	224ba2a3-1a93-29c8-e063-6394a90a9bef	2025-01-30	Warnings	Exact identifier application number: M012
Extra Strength Nite-Time Pain Relief	430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET	WALGREENS	c25cff5a-93f5-62aa-e053-2a95a90aa7b4	2025-01-30	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALGREENS	dbf5c814-4e69-13ac-e053-2a95a90a49a3	2025-01-30	Warnings	Exact identifier application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	WALGREENS	f3770976-de73-52b8-e053-2995a90aad4f	2025-01-30	Warnings	Exact identifier application number: M012
Dextromethorphan HBr and Guaifenesin Oral Solution	DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION	KESIN PHARMA CORPORATION	284eae44-81bc-400c-e063-6394a90af446	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26c82bc3-5753-4d56-96a4-a3f9c8c267d0	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	8095b211-8ae7-44e5-b89a-b7f730e28d51	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2cf2f35b-5d59-e3ff-e063-6294a90a9b45	2025-01-30	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Rite Aid Corporation	8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5	2025-01-30	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cold and Flu	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	RB Health (US) LLC	2ce20ab5-5f2d-1c97-e063-6394a90ad67b	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	97b137c9-0bec-409a-91f7-e298c296578b	2025-01-29	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS	1dc17665-62ce-f7f5-e063-6294a90af851	2025-01-29	Warnings	Exact identifier application number: M012
UP AND UP NO DRIP NASAL	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	760d6d0f-00fc-40bc-858d-83a0827d139f	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	51e48201-bb62-4e89-85eb-e4a416f93522	2025-01-29	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	8c878e47-94f4-484f-bdd8-6d87ac2440d8	2025-01-28	Warnings	Exact identifier application number: M012
Cough and Cold Therapy	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088be461-7afc-586a-e063-6294a90a700b	2025-01-27	Warnings	Exact identifier application number: M012
Cough and Cold Therapy For Kids	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088df369-114c-db4f-e063-6394a90acfac	2025-01-27	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