Children Afrin Extra Moisturizing Stuffy Nose Pump Mist

Product NDC: 11523-0091
11-digit product format: 115230091
Labeler code: 11523
Product ID: 11523-0091_4526d3b2-bf61-2bf3-e063-6394a90a4fad
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Bayer HealthCare LLC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-03
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .025 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: Children Afrin Extra Moisturizing Stuffy Nose Pump Mist
Brand name suffix: Stuffy Nose Pump Mist
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.025 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
2606550	Internal RxNorm lookup
2606551	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
e3b239bd-ffc7-600c-e053-2a95a90a3b3b	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	SPL version
11523-0091-1	Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist	15 mL in 1 BOTTLE, PUMP	SPRAY, METERED	15	9
11523-0091-1	Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist	1 in 1 CARTON	SPRAY, METERED	1	9
11523-0091-2	Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist	2 in 1 CARTON	SPRAY, METERED	2	9
11523-0091-2	Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist	15 mL in 1 BOTTLE, PUMP	SPRAY, METERED	15	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-0091-1	ML - Milliliter	11523-0091	eb72e68d-8726-4f9d-bb27-a955e44153b0	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-0091	CHILDREN AFRIN EXTRA MOISTURIZING STUFFY NOSE PUMP MIST STUFFY NOSE PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]	8	Current NDC, Legacy NDC, 4 package rows	20241208_e3b239bd-ffc7-600c-e053-2a95a90a3b3b.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 142 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier application number: M012
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	Warnings	Exact identifier application number: M012
Severe Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	d40d6fd1-3f84-40ae-ab7e-04569eb41617	2024-10-30	Warnings	Exact identifier application number: M012
equaline nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	4e0c6ad6-81ef-4b0e-b2eb-44256faf7358	2024-10-30	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fbe2c0-7749-4c8a-e063-6394a90a7c6e	2024-10-30	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	130e68d1-9048-49c1-beee-490eecaed2d9	2024-10-30	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	02f3e739-3153-412f-b2cd-6f01dcd5875b	2024-10-30	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
2606551	Afrin 0.025 % Nasal Spray	PSN	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606550	oxymetazoline hydrochloride 0.025 % Nasal Spray	PSN	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606551	oxymetazoline hydrochloride 0.25 MG/ML Nasal Spray [Afrin]	SBD	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606550	oxymetazoline hydrochloride 0.25 MG/ML Nasal Spray	SCD	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606551	Afrin 0.025 % Nasal Spray	SY	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606551	Afrin 0.25 MG/ML Nasal Spray	SY	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9
2606550	oxymetazoline hydrochloride 0.025 % Nasal Spray	SY	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-0091-1	11523009101	1 BOTTLE, PUMP in 1 CARTON (11523-0091-1) / 15 mL in 1 BOTTLE, PUMP	2022-07-14	0000-00-00	No	No	Current
11523-0091-2	11523009102	2 BOTTLE, PUMP in 1 CARTON (11523-0091-2) / 15 mL in 1 BOTTLE, PUMP	2022-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Afrin ® Extra Moisturizing Stuffy Nose Pump Mist	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL	9