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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	00689aa5-ed39-4c9a-92b8-105d2c0e2e15	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	9aca1a68-893c-4770-8a48-d5d678058253	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	d26b5143-aa07-4114-a6ba-4f503aadd46f	2026-05-27	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	37533188-8c91-428b-a796-c5afd9e4959f	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	8252cdec-b668-4450-b045-e093479ab542	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Nighttime Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	27f9d2db-38ce-41d2-8f1a-0eb171600274	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Sore Throat	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	b37b786e-0cce-419d-94ed-3b64a1eb1201	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	a43d59f9-3a6c-4a7c-b98d-b86d6035f716	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Relief Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	5700ef26-ffa6-480a-bf36-bd5111799e9b	2026-05-27	Warnings	Exact identifier application number: M012
Air Power	GUAIFENESIN	Schwabe North America, Inc	5cdefc7a-6242-4681-88a3-04422a1d48d3	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	adb658c8-db8d-4db6-80c8-e0f2de88a2de	2026-05-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	c71427d4-707f-411f-8bd4-133517a9992b	2026-05-26	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CVS PHARMACY, INC	643e929d-9e62-4260-91ee-e88a184dd7cd	2026-05-26	Warnings	Exact identifier application number: M012
TopCare Day Time Nite Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	c00ff684-acaf-4fbe-bc74-7e48751b927d	2026-05-26	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PE	PHENYLEPHRINE	Cabinet Health P.B.C.	4e75da23-35f2-431c-92cb-c2c4cb3f09f1	2026-05-26	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	13492631-d5de-4562-a201-664f7d3591de	2026-05-26	Warnings	Exact identifier application number: M012
Sinufrin Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	52a2e5f9-e0a2-02f7-e063-6294a90a3ae9	2026-05-25	Warnings	Exact identifier application number: M012
Cough Suppressant Adult	DEXTROMETHORPHAN HYDROBROMIDE	Rugby Laboratories	47b713bd-4c1e-f44a-e063-6294a90a63d3	2026-05-25	Warnings	Exact identifier application number: M012
ClorRelief	CHLORPHENIRAMINE MALEATE	FERRER MEDICAL INNOVATIONS LLC	db729011-f72f-5911-e053-2a95a90a68bf	2026-05-22	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	74ff4f0d-7952-4b74-b1b2-5a2beab91f7c	2026-05-22	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