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		2026-10-15

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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	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