SinuFrin Plus

Product NDC: 13709-232
11-digit product format: 137090232
Labeler code: 13709
Product ID: 13709-232_0eb0fd3c-87e2-405d-e063-6294a90ae06f
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: NeilMed Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-07-15
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: 7.5 mg/15mL
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: SinuFrin Plus
Brand name suffix: NeilMed
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	7.5 mg/15mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup
1313914	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
99afe6a6-1350-49c6-9347-b7e531e35925	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13709-232-05	SinuFrin PlusNeilMed	15 mL in 1 BOX	SPRAY	15	9
13709-232-06	SinuFrin PlusNeilMed	15 mL in 1 BOTTLE	SPRAY	15	9
13709-232-12	SinuFrin PlusNeilMed	1 in 1 CARTON	SPRAY	1	9
13709-232-12	SinuFrin PlusNeilMed	30 mL in 1 BOTTLE	SPRAY	30	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
ALOE	INACTIVE INGREDIENT	V5VD430YW9	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13709-232	SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240112_99afe6a6-1350-49c6-9347-b7e531e35925.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	99afe6a6-1350-49c6-9347-b7e531e35925	9
1313914	Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal Spray	PSN	99afe6a6-1350-49c6-9347-b7e531e35925	9
1313914	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]	SBD	99afe6a6-1350-49c6-9347-b7e531e35925	9
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	99afe6a6-1350-49c6-9347-b7e531e35925	9
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	99afe6a6-1350-49c6-9347-b7e531e35925	9
1313914	Sinufrin Plus 0.05 % Nasal Spray	SY	99afe6a6-1350-49c6-9347-b7e531e35925	9
1313914	Sinufrin Plus 0.5 MG/ML Nasal Spray	SY	99afe6a6-1350-49c6-9347-b7e531e35925	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13709-232-05	13709023205	15 mL in 1 BOX (13709-232-05)	15 ml	2012-07-15	0000-00-00	No	No	Current
13709-232-06	13709023206	15 mL in 1 BOTTLE (13709-232-06)	15 ml	2012-07-15	0000-00-00	No	No	Current
13709-232-12	13709023212	1 BOTTLE in 1 CARTON (13709-232-12) / 30 mL in 1 BOTTLE	1 bottle	2021-04-21	0000-00-00	No	No	Current