FDA.reportPublic FDA data

Quality Choicel

Product NDC
83324-211
11-digit product format
833240211
Labeler code
83324
Product ID
83324-211_357bceda-02df-94d9-e063-6394a90a64ae
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-02
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

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
Quality Choicel
Brand name suffix
Nasal Mist Extra Moisturizing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
460f0cc1-6a85-4d79-af87-a94fd151769eAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-211-01Quality ChoicelNasal Mist Extra Moisturizing1 in 1 CARTONSPRAY11
83324-211-01Quality ChoicelNasal Mist Extra Moisturizing30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-211-01ML - Milliliter83324-21128707c66-2bdf-4506-a48b-c887009b88c912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-211QUALITY CHOICEL NASAL MIST EXTRA MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]1Current NDC, 2 package rows20250521_460f0cc1-6a85-4d79-af87-a94fd151769e.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 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Drops Honey Lemon with SugarMENTHOLLidl US LLC4ad9398f-7488-6eaf-e054-00144ff8d46c2024-11-05WarningsExact identifier
application number: M012
rexall dm cough and congestion reliefDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLC906838b1-a742-4728-944d-42b687b8cd592024-11-05WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINH E B7c24c59c-7549-4c64-95f8-4bf755cd6f612024-11-05WarningsExact identifier
application number: M012
equate adult tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inc3592e000-a6c6-47fe-8bb0-9341c65c29592024-11-05WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company756794b0-8d3b-4732-947c-a407caf400e22024-11-05WarningsExact identifier
application number: M012
basic care tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCc6863e31-e1b9-40ff-ae2e-4aec86b4acc02024-11-05WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a2024-11-05WarningsExact identifier
application number: M012
Childrens Sudafed PE NASAL DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d2024-11-04WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.164b2559-2d3f-431e-a03c-07e86731af5c2024-11-04WarningsExact identifier
application number: M012
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B3c301993-642a-487c-96a2-ebc4ef90dc882024-11-02WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1341744c-43c3-462b-b93c-1e46476fd9352024-11-01WarningsExact identifier
application number: M012
Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy43784616-1afd-4ff7-8fee-6ac389f616a22024-11-01WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLC28ef87e8-29e5-444d-b1f7-5c38a7f758d32024-11-01WarningsExact identifier
application number: M012
Good Sense Severe NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Company0e3c36c9-d45b-41b9-891d-a42d854295f92024-11-01WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company7dc3941a-e5f8-4caa-bae5-6a0d075295cb2024-11-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN460f0cc1-6a85-4d79-af87-a94fd151769e1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD460f0cc1-6a85-4d79-af87-a94fd151769e1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY460f0cc1-6a85-4d79-af87-a94fd151769e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-211-01833240211011 BOTTLE, SPRAY in 1 CARTON (83324-211-01) / 30 mL in 1 BOTTLE, SPRAY2025-05-02NoNoCurrent