Afrin

Product NDC: 11523-1167
11-digit product format: 115231167
Labeler code: 11523
Product ID: 11523-1167_452362c1-c953-c5d7-e063-6294a90ad7c4
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Bayer HealthCare LLC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1975-07-14
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11523-1167	11523-1167-4	D	Discontinued by firm		2026-10-21

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 · 1 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11523-1167	11523-1167-4	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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: Afrin
Brand name suffix: Original
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup
1000992	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
89c165ba-3ad5-49b5-a5bb-423dc8e15bad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-1167-1	AfrinOriginal	6 mL in 1 BOTTLE, SPRAY	SPRAY	6	12
11523-1167-2	AfrinOriginal	21 mL in 1 BOTTLE, SPRAY	SPRAY	21	12
11523-1167-2	AfrinOriginal	2 in 1 CARTON	SPRAY	2	12
11523-1167-3	AfrinOriginal	1 in 1 CARTON	SPRAY	1	12
11523-1167-3	AfrinOriginal	20 mL in 1 BOTTLE, SPRAY	SPRAY	20	12
11523-1167-4	AfrinOriginal	3 in 1 CARTON	SPRAY	3	12
11523-1167-4	AfrinOriginal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	12
11523-1167-5	AfrinOriginal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	12
11523-1167-5	AfrinOriginal	1 in 1 CARTON	SPRAY	1	12
11523-1167-6	AfrinOriginal	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	12
11523-1167-6	AfrinOriginal	1 in 1 CARTON	SPRAY	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-1167-3	ML - Milliliter	11523-1167	e6b61680-eaad-4ff1-a0d4-d25116e1ada1	1	2015-10-02
11523-1167-5	ML - Milliliter	11523-1167	892df7b8-5889-48d3-9cdf-70a8f33e8c49	1	2013-10-17
11523-1167-6	ML - Milliliter	11523-1167	5797e12f-28cc-49e5-bfd1-5dc75045522c	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Oxymetazoline hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-1167	AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]	11	Current NDC, Legacy NDC, 11 package rows	20241208_89c165ba-3ad5-49b5-a5bb-423dc8e15bad.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 39 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	BETTER LIVING BRANDS, LLC	46adbf94-5b93-ee64-e063-6294a90a1144	2026-04-11	Warnings	Exact identifier application number: M012
good sense night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	0c79357a-b79d-4952-8e6d-ef3d60dde2fa	2026-04-10	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	88d27c25-a305-4398-9590-df10d2504b01	2026-04-09	Warnings	Exact identifier application number: M012
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb	2026-04-09	Warnings	Exact identifier application number: M012
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	e20b1093-d77f-4c39-b105-adaa1b82ea76	2026-04-09	Warnings	Exact identifier application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	4f0c1b8e-3fb1-ccf2-e063-6394a90acd15	2026-04-09	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Lidl US LLC	b26ac105-f8e4-4ad0-8a26-9fdf30c01700	2026-04-09	Warnings	Exact identifier application number: M012
Wal Dryl Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	09de28cd-fa60-4af7-b7cc-cf74c00a3531	2026-04-09	Warnings	Exact identifier application number: M012
Tussin DM Max NIGHTTIME	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	d10a413e-22a6-4799-8367-5777831756a9	2026-04-09	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	80d25e23-b108-4eb1-88c7-73fe9da8f942	2026-04-09	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR AND GUAIFENESIN	L.N.K. International, Inc.	2fea3533-8218-4875-affe-5b33a22c553a	2026-04-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Plus Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Kenvue Brands LLC	4e60e1ad-4ad4-c329-e063-6294a90ab318	2026-04-08	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4592d547-556f-4eec-8faf-6ff9a92e46c8	2026-04-08	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	e24121d2-c9d2-4bbd-869e-eeed7e2bb881	2026-04-08	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	8460d4f9-8d7b-4ae4-8047-c2010d9c8013	2026-04-08	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	d2dab450-cf82-4be2-a4e2-630295fb59ab	2026-04-08	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	4657c02b-887b-4746-8a78-83a72465e07b	2026-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	33646fab-79a5-4f10-8ac0-48423eac9b56	2026-04-07	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	76e19b9a-3bdb-479a-9503-9e8250109c84	2026-04-07	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	7959ea00-2a41-4c3c-8c58-85795ebd2afc	2026-04-06	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
1000992	Afrin 0.05 % Nasal Spray	PSN	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000992	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]	SBD	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000992	Afrin 0.05 % Nasal Spray	SY	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000992	Afrin 0.5 MG/ML Nasal Spray	SY	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	12
1000992	Afrin 0.05 % Nasal Spray	PSN	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000992	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]	SBD	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000992	Afrin 0.05 % Nasal Spray	SY	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000992	Afrin 0.5 MG/ML Nasal Spray	SY	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	65bf1556-f234-9439-e053-2a91aa0a3194	5
1000992	Afrin 0.05 % Nasal Spray	PSN	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000992	Afrin 0.05 % Nasal Spray	PSN	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000992	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]	SBD	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000992	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]	SBD	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000992	Afrin 0.05 % Nasal Spray	SY	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000992	Afrin 0.05 % Nasal Spray	SY	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000992	Afrin 0.5 MG/ML Nasal Spray	SY	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000992	Afrin 0.5 MG/ML Nasal Spray	SY	af46c67d-f01f-83f8-e053-2a95a90aa70f	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	1387514f-3c4b-46d0-873c-9eedf9721327	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	af46c67d-f01f-83f8-e053-2a95a90aa70f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-1167-1	11523116701	6 mL in 1 BOTTLE, SPRAY (11523-1167-1)	6 ml	2022-11-16	0000-00-00	No	No	Current
11523-1167-2	11523116702	2 BOTTLE, SPRAY in 1 CARTON (11523-1167-2) / 21 mL in 1 BOTTLE, SPRAY		1975-07-14	0000-00-00	No	No	Current
11523-1167-3	11523116703	1 BOTTLE, SPRAY in 1 CARTON (11523-1167-3) / 20 mL in 1 BOTTLE, SPRAY		1975-07-14	0000-00-00	No	No	Current
11523-1167-4	11523116704	3 BOTTLE, SPRAY in 1 CARTON (11523-1167-4) > 30 mL in 1 BOTTLE, SPRAY		1975-07-14	0000-00-00	No	No	Current
11523-1167-5	11523116705	1 BOTTLE, SPRAY in 1 CARTON (11523-1167-5) / 30 mL in 1 BOTTLE, SPRAY		1975-07-14	0000-00-00	No	No	Current
11523-1167-6	11523116706	1 BOTTLE, SPRAY in 1 CARTON (11523-1167-6) / 15 mL in 1 BOTTLE, SPRAY		1975-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Afrin Original Nasal Spray	JC World Bell Wholesale Co., Inc.	2026-08-31	HUMAN OTC DRUG LABEL	2
Afrin ® Original	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL	12
Afrin	Navajo Manufacturing Company Inc.	2024-10-02	HUMAN OTC DRUG LABEL	5
Afrin Original Nasal Spray	JC World Bell Wholesale Co., Inc.	2023-11-05	HUMAN OTC DRUG LABEL	3
Afrin Original Nasal Spray	Bayer HealthCare LLC.	2023-11-05	HUMAN OTC DRUG LABEL	3