FDA.reportPublic FDA data

NDC 11523-0147-01 - Afrin No Drip Pump Mist Bundle Pack

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
11523-0147
Requested NDC
11523-0147-01
Package NDCs from labels
11523-0147-1, 11523-0147-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Afrin ® No Drip Original/Night Pump Mist Bundle PackBayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0147-1Afrin No DripPump Mist Bundle Pack1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0147AFRIN NO DRIP PUMP MIST BUNDLE PACK (OXYMETAZOLINE HYDROCHLORIDE) KIT [BAYER HEALTHCARE LLC.]1Current NDC, 1 package rows20240427_16c52c79-baec-87db-e063-6294a90a3b3b.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 36 of 254 · 5,073 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
application number: M012
Mucinex ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4cee80e5-e412-e832-e063-6394a90aeb902026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.5258ea3f-87f1-7f86-e063-6394a90ab82f2026-05-21WarningsExact identifier
application number: M012
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
daytime nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Inc80abb6b8-b0d5-4f19-8588-50b8717510bb2026-05-21WarningsExact identifier
application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbdd6c-79c3-0726-e053-2a95a90a46512026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideLIQUID HAND SOAPAMAZON.COM SERVICES LLC1bf99b68-c8a7-d88c-e063-6294a90ad2d22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacy Inc.e582bdcf-0d8b-39f1-e053-2995a90a01f22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f58da5-9b8b-a0f4-e063-6294a90a77d72026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbfc4e-d118-5202-e053-2995a90aac6c2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care423f5f82-8521-65aa-e063-6294a90a11802026-05-20WarningsExact identifier
unii: F5UM2KM3W7
LIDLBENZALKONIUM CHLORIDELIDL US LLCca13681e-4cdd-30c7-e053-2a95a90ad05a2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
ALKA SELTZER COLD Cold and Cough FastACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5241b11a-72c8-5e67-e063-6394a90a43532026-05-20WarningsExact identifier
application number: M012
WINCO CITRUS LHSBENZALKONIUM CHLORIDEWINCO FOODS, LLC261d768c-8ec7-4b16-e063-6294a90a23a02026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4bae240c-70ce-e9c2-e063-6394a90a5f3d2026-05-20WarningsExact identifier
application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC85f7d60b-32ec-4ec2-86ec-f677093bce1d2026-05-20WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.