SinuFrin

Product NDC: 13709-231
11-digit product format: 137090231
Labeler code: 13709
Product ID: 13709-231_0eb0d276-2eba-1c8d-e063-6294a90ae9ff
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	13709-231		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	13709-231	13709-231-04	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	13709-231	13709-231-07	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
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
f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
13709-231-04	2020-04-18	Drug Facts
13709-231-07	2020-04-18	Drug Facts
13709-231-04	2020-01-31	Drug Facts
13709-231-07	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13709-231-04	SinuFrinNeilMed	15 mL in 1 BOX	SPRAY	15	7
13709-231-07	SinuFrinNeilMed	15 mL in 1 BOTTLE	SPRAY	15	7
13709-231-12	SinuFrinNeilMed	30 mL in 1 BOTTLE	SPRAY	30	7
13709-231-12	SinuFrinNeilMed	1 in 1 CARTON	SPRAY	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13709-231	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	7	Current NDC, Legacy NDC, 4 package rows	20240112_f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae.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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Exact identifier application number: M012
Cough and Runny Nose Childrens Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	TOP CARE (Topco Associates LLC)	6f04bd51-093c-4624-aef3-0145ac387386	2026-06-01	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	694a3116-1b75-42cd-bbcf-d19831c2d796	2026-06-01	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	cf31538c-9eee-4c81-80cb-66eecabf0aff	2026-06-01	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	155e07b3-0a08-3be8-e063-6394a90a7635	2026-05-31	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Nighttime	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	156033ae-b16a-007b-e063-6294a90a7445	2026-05-31	Warnings	Exact identifier application number: M012
Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	ebf8c82d-a653-4c02-893b-61704901acbb	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Amerisource Bergen	934c7b91-3cba-47f0-8efa-77216f3f15c4	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Medicine	DIPHENHYDRAMINE HCL	COSTCO WHOLESALE CORPORATION	d9f03e11-d11f-43ee-8ed0-9e07d1058f66	2026-05-29	Warnings	Exact identifier application number: M012
Cold Childrens, Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d	2026-05-29	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	3598ac5b-29f9-f002-e063-6294a90a62cb	2026-05-28	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2026-05-28	Warnings	Exact identifier application number: M012
Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	a7ab2140-de09-158f-e053-2a95a90a25a0	2026-05-28	Warnings	Exact identifier application number: M012
Kids Multi Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	2d918ec8-3098-1d09-e063-6294a90a9e8f	2026-05-28	Warnings	Exact identifier application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Genexa Inc.	213fe898-dace-9a0f-e063-6394a90afd64	2026-05-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Lemon Flavor	MENTHOL	Medical Group Care LLC	556628ab-e233-92fe-e063-6394a90a0090	2026-05-28	Warnings	Exact identifier application number: M012
Sinus Decongestion PE	PHENYLEPHRINE HCL	Kroger Company	68eff734-177e-4999-9126-6b92bb204107	2026-05-28	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	ARMY AND AIR FORCE EXCHANGE SERVICE	ff39084f-ab2f-48ed-ac62-837f7fff2b65	2026-05-28	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Select Consumer Group LLC	52c5fda0-c358-72e8-e063-6394a90a3f68	2026-05-27	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	16637d54-8049-d3ce-e063-6394a90aafc9	2026-05-27	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	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1313914	Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal Spray	PSN	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1313914	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]	SBD	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1313914	Sinufrin Plus 0.05 % Nasal Spray	SY	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7
1313914	Sinufrin Plus 0.5 MG/ML Nasal Spray	SY	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13709-231-04	13709023104	15 mL in 1 BOX (13709-231-04)	15 ml	2012-07-15	0000-00-00	No	No	Current
13709-231-07	13709023107	15 mL in 1 BOTTLE (13709-231-07)	15 ml	2012-07-15	0000-00-00	No	No	Current
13709-231-12	13709023112	1 BOTTLE in 1 CARTON (13709-231-12) / 30 mL in 1 BOTTLE	1 bottle	2021-04-21	0000-00-00	No	No	Current