FDA.reportPublic FDA data

Family Wellness Oxymetazoline Sinus Severe

Product NDC
55319-827
11-digit product format
553190827
Labeler code
55319
Product ID
55319-827_c2418891-74c7-4963-9ac2-26b745273a6a
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline
Dosage form
SPRAY
Route
NASAL
Labeler
FAMILY DOLLAR (Family Wellness)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-30
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
50 mg/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
Family Wellness Oxymetazoline Sinus Severe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE50 mg/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
13237d31-c60a-49f8-9b96-4414cf766a08Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-827-30Family Wellness Oxymetazoline Sinus Severe30 mL in 1 BOTTLESPRAY303
55319-827-30Family Wellness Oxymetazoline Sinus Severe1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-827FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE (OXYMETAZOLINE) SPRAY [FAMILY DOLLAR (FAMILY WELLNESS)]3Current NDC, 2 package rows20241122_13237d31-c60a-49f8-9b96-4414cf766a08.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 40 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
application number: M012
Cold and AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDOLGENCORP, LLCb55452e1-25d0-4db5-9621-83f21ec6c2982026-04-06WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEStrategic Sourcing Services LLCc9fa8d93-d9d6-4206-a13d-32b9e7555e7f2026-04-02WarningsExact identifier
application number: M012
Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company6aaed3fe-ce35-4533-aea4-80096ce8e57a2026-04-02WarningsExact identifier
application number: M012
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLLidl US LLC7227b330-590b-4731-8a58-e05a0233dd8a2026-04-01WarningsExact identifier
application number: M012
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
application number: M012
Sanatos Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC4c26be18-733a-e4a8-e063-6294a90a8b022026-04-01WarningsExact identifier
application number: M012
Sanatos Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC4c26c8bf-0143-ddca-e063-6294a90a35522026-04-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsExact identifier
application number: M012
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsExact identifier
application number: M012
Dr Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCalmCo LLC3f156679-7a91-aff1-e063-6394a90a18f62026-03-31WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINA-S Medication Solutionsc26da6e0-ab1c-46c2-acf5-0074958c03cd2026-03-31WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leaderba174fcc-da1e-420c-bf9c-179ad65c28482026-03-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAmerisource Bergen8e0c6f8d-559c-45de-9362-1b713fd78a7a2026-03-30WarningsExact identifier
application number: M012
Dr. Simi Daytime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MGFarmacias De Similares TX LLC4e448fd0-cb6b-b69b-e063-6394a90afde82026-03-30WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN13237d31-c60a-49f8-9b96-4414cf766a083
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD13237d31-c60a-49f8-9b96-4414cf766a083
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY13237d31-c60a-49f8-9b96-4414cf766a083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-827-30553190827301 BOTTLE in 1 CARTON (55319-827-30) / 30 mL in 1 BOTTLE1 bottle2023-09-30NoNoCurrent