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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	869e950c-5861-4840-aaad-b0342790d62b	2026-02-10	Warnings	Exact identifier application number: M012
CareOne Night TIme Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25	2026-02-10	Warnings	Exact identifier application number: M012
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Sportpharm LLC	d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	f3fc270a-92fc-46d5-b187-44e875c3abb9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	d5c8b248-6d82-4eac-881c-0b9d0a0de8f1	2026-02-09	Warnings	Exact identifier application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	d07112dd-27df-46cc-b7c3-af8ba7601d06	2026-02-09	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	48f7933e-6582-638c-e063-6394a90abfe5	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Retail Business Services, LLC	4fb46860-2bf9-41a7-89eb-31c259c61107	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Sportpharm LLC	909dacfa-50d3-4bcf-b2df-5405427cfaad	2026-02-06	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f91b7c1f-e074-4767-b9c8-dbf1937a6a0f	2026-02-06	Warnings	Exact identifier application number: M012
Severe Allergy And Sinus Headache Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	b3c744b8-aa93-505d-f8cf-07995da4283d	2026-02-06	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	WinCo Foods, LLC	911e6a51-c0f0-491a-b70c-00011ed5e35b	2026-02-06	Warnings	Exact identifier application number: M012
Severe Sinus Daytime, Non-Drowsy	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cc0dc951-5024-4517-9d38-a01699407e7e	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Pharmacy Value Alliance, LLC	d836c3e2-3b69-41f3-b166-21270550e8ab	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Publix Super Markets, Inc.	81b1d5bb-f813-4f79-9559-2494db33ad3c	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	6499f854-2995-48cb-9c80-be6524b3db43	2026-02-05	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	52a398eb-e593-458b-9c42-6f653ca391be	2026-02-04	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Hy-Vee, Inc.	446de381-6685-748d-e063-6394a90a1b73	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	85aadc86-d979-41a1-849a-e2ccc9014429	2026-02-04	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	fa8c154c-56c6-47de-8e43-9e012b4be95f	2026-02-04	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