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 134 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	177e3247-402d-98e4-e063-6294a90ae068	2024-11-26	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu, CVP	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET	Lil' Drug Store Products, Inc.	e7a27773-69d6-9e07-e053-2a95a90af8ea	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	4361912e-4b56-4743-b11d-acfb94482a2e	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	413d82d3-a896-4f15-9fca-c1b7b9a1ee63	2024-11-25	Warnings	Exact identifier application number: M012
Night Cold Flu Cough and Allergy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0	2024-11-25	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	cbd3a905-1c41-4cb0-8df6-36784430d627	2024-11-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	7a28d0fe-0e0a-453a-b604-1cc784dd153c	2024-11-25	Warnings	Exact identifier application number: M012
Cough and Cold plus	ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	c483d88f-cb0a-4dd6-b3ae-559521782ba6	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	a0b01aef-4248-4d41-862c-0c8884dfca5e	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	3af20739-6794-42e0-b404-3f0401d10a6d	2024-11-25	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.	ffc7e1e2-b664-461b-963d-764bad2f983f	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	0f3b1404-9252-470a-aa8c-b360c85731f3	2024-11-25	Warnings	Exact identifier application number: M012
Maximum Strength-Cough and Chest Congestion DM	MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	d1830989-fe82-4f08-8618-78979fcef568	2024-11-25	Warnings	Exact identifier application number: M012
ASP Daytime PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b84f2392-0b24-4af0-80f7-c45454093f51	2024-11-25	Warnings	Exact identifier application number: M012
ASP Nighttime Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	d8756d1f-baf5-412d-a493-a1c051eae302	2024-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Exact identifier application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	cb68eef0-b027-4bf1-b78f-f31844a8c06c	2024-11-22	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Exact identifier application number: M012
12 Hour Nasal Decongestant Extra Moisturizing	NASAL SPRAY	WinCo Foods LLC	13fbde45-958c-455f-b766-f6a34342ee95	2024-11-21	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	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