FDA.reportPublic FDA data

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
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.025 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2606550Internal RxNorm lookup
2606551Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3b239bd-ffc7-600c-e053-2a95a90a3b3bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0091-1Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED159
11523-0091-1Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist1 in 1 CARTONSPRAY, METERED19
11523-0091-2Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist2 in 1 CARTONSPRAY, METERED29
11523-0091-2Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0091-1ML - Milliliter11523-0091eb72e68d-8726-4f9d-bb27-a955e44153b012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0091CHILDREN AFRIN EXTRA MOISTURIZING STUFFY NOSE PUMP MIST STUFFY NOSE PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 4 package rows20241208_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 132 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb373a3a8-68c4-0187-e053-2995a90aad622024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
application number: M012
Meijer Medicated Chest Rub, 3.53 oz. LavenderMENTHOL, CAMPHOR, EUCALYPTUS OILMeijer Distribution22516f25-b8aa-7511-e063-6394a90a61252024-12-03WarningsExact identifier
application number: M012
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
application number: M012
Tenalif Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd94e7-1808-3bb3-e063-6294a90a41402024-12-03WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC31531f90-8933-46ab-b722-cb63e77386392024-12-03WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLCf45f3ab4-5e10-3004-e053-2a95a90a0cb42024-12-03WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.2861b801-e778-822d-e063-6394a90aa1a82024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCfe0cf681-f42c-430c-8429-f7ba4bc5a9762024-12-02WarningsExact identifier
application number: M012
Allergy MultisymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5a5aa2ee-51b7-4698-bb27-3fb9d01bbea52024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association0ea270b7-9c28-49fb-9615-c4afdbdbc8f12024-12-02WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC0955d856-cc4e-4ef2-8bc0-1a632a5b5f792024-12-02WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC40c9c90d-6c9e-40d0-921d-1fd34eff90bb2024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3d068d30-9a00-49d7-bbe9-d6b53c19e86d2024-12-02WarningsExact identifier
application number: M012
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.76724432-ff3c-404f-ba1f-5af68e3ab8c42024-12-02WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.73d4fc82-8508-44f8-83ca-9f32c5cd847b2024-12-02WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606551Afrin 0.025 % Nasal SprayPSNe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606550oxymetazoline hydrochloride 0.025 % Nasal SprayPSNe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606551oxymetazoline hydrochloride 0.25 MG/ML Nasal Spray [Afrin]SBDe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606550oxymetazoline hydrochloride 0.25 MG/ML Nasal SpraySCDe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606551Afrin 0.025 % Nasal SpraySYe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606551Afrin 0.25 MG/ML Nasal SpraySYe3b239bd-ffc7-600c-e053-2a95a90a3b3b9
2606550oxymetazoline hydrochloride 0.025 % Nasal SpraySYe3b239bd-ffc7-600c-e053-2a95a90a3b3b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-0091-1115230091011 BOTTLE, PUMP in 1 CARTON (11523-0091-1) / 15 mL in 1 BOTTLE, PUMP2022-07-140000-00-00NoNoCurrent
11523-0091-2115230091022 BOTTLE, PUMP in 1 CARTON (11523-0091-2) / 15 mL in 1 BOTTLE, PUMP2022-12-020000-00-00NoNoCurrent