Ultra Fine Mist

Product NDC: 55910-627
11-digit product format: 559100627
Labeler code: 55910
Product ID: 55910-627_a09bbef7-050d-4d10-9baa-c9549d85850b
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: DOLGENCORP, INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-18
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Ultra Fine Mist
Brand name suffix: Sinus Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	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
5f134840-2465-4585-a85d-08d746f76f7a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-627-30	Ultra Fine MistSinus Relief	1 in 1 CARTON	SPRAY	1		6
55910-627-30	Ultra Fine MistSinus Relief	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-627	ULTRA FINE MIST SINUS RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240823_5f134840-2465-4585-a85d-08d746f76f7a.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 83 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012
Desgen Pediatric	DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	12425c1b-8bdc-446b-83dd-95e05a4d9b8c	2025-12-04	Warnings	Exact identifier application number: M012
Presgen B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5befa829-32bd-4978-8a0e-1d6513ff37a4	2025-12-03	Warnings	Exact identifier application number: M012
TUSSLIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kramer Novis	987e19a5-032f-44e9-b4c7-8a764d502695	2025-12-03	Warnings	Exact identifier application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	450e8974-8ff8-4b82-e063-6394a90a9366	2025-12-03	Warnings	Exact identifier application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store Products, Inc.	4510223f-1c88-2796-e063-6394a90a18ac	2025-12-03	Warnings	Exact identifier application number: M012
Carolina Crud Crusher	DEXTROMETHORPHAN HBR, GUAIFENESIN	Weeks & Leo Co., Inc.	0b606683-7d68-cca5-e063-6394a90a6f58	2025-12-03	Warnings	Exact identifier application number: M012
Capmist DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Capital Pharmaceutical, LLC	63733ac3-859e-4a8e-8717-d852bd303408	2025-12-03	Warnings	Exact identifier application number: M012
ALA-HIST IR	DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	0d203b5c-8b10-428b-8703-17be6b4ce6eb	2025-12-03	Warnings	Exact identifier application number: M012
ALAHIST DM	DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	fdaa062d-110e-798d-e053-6394a90a755c	2025-12-03	Warnings	Exact identifier application number: M012
Alahist D	PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	a1b8533a-ef8b-57cc-e053-2995a90a5d9e	2025-12-03	Warnings	Exact identifier application number: M012
Alahist PE	DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	ada2d582-5813-2029-e053-2a95a90ae567	2025-12-03	Warnings	Exact identifier application number: M012
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	L.N.K. International, Inc.	9f2daffc-1904-4d64-9f84-689c88601e06	2025-12-03	Warnings	Exact identifier application number: M012
Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	d291faa9-894e-421c-8115-8a8c2a937172	2025-12-03	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	5f134840-2465-4585-a85d-08d746f76f7a	6
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	5f134840-2465-4585-a85d-08d746f76f7a	6
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	5f134840-2465-4585-a85d-08d746f76f7a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-627-30	55910062730	1 BOTTLE, SPRAY in 1 CARTON (55910-627-30) / 30 mL in 1 BOTTLE, SPRAY	2020-09-18	0000-00-00	No	No	Current