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 28 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Cough and Congestion Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8b5d391b-6c23-44c3-81d0-c08822bf6d01	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	e048cd53-a3cd-484f-a972-4cb49791dba3	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	b8132c81-5291-431a-ad3a-ec8a3eb21c19	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	19105007-0193-0764-e063-6294a90a01a4	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	34fd2458-9acd-cdf7-e063-6394a90a3d0a	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	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