FDA.reportPublic FDA data

Family Dollar

Product NDC
55319-715
11-digit product format
553190715
Labeler code
55319
Product ID
55319-715_db88cc6b-ff9a-4d8d-a7aa-3ce1d6a6f3c2
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal
Dosage form
SPRAY
Route
NASAL
Labeler
FAMILY DOLLAR SERVICES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-28
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
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
Family Dollar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

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
55319-715-30Family Dollar1 in 1 CARTONSPRAY18
55319-715-30Family Dollar30 mL in 1 BOTTLE, SPRAYSPRAY308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-715FAMILY DOLLAR (NASAL) SPRAY [FAMILY DOLLAR SERVICES INC]7Current NDC, Legacy NDC, 2 package rows20240905_8ddf601b-c851-4604-b60c-f190fb838231.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 90 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e2025-11-07WarningsExact identifier
application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Companyff0bffee-9a36-8246-e053-6294a90a86c72025-11-06WarningsExact identifier
application number: M012
Xlear Nasal DecongestantNASAL SPRAYXlear Inc.1c1db71a-47d0-42ac-8cbe-95e76dca185f2025-11-06WarningsExact identifier
application number: M012
Robitussin Honey Cough DM Day Night Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLC1bbd0157-06e6-4a3b-bac9-91ac879ba0892025-11-06WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant Phenylephrine HClPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.21676b0c-6be2-464c-ae91-92e5f0d0087d2025-11-06WarningsExact identifier
application number: M012
COLD AND FLU SEVERE Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.04715af5-e861-496c-834a-233eb73125562025-11-06WarningsExact identifier
application number: M012
Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores Inc1a1f41c4-5430-4cff-873e-6547dadc87792025-11-06WarningsExact identifier
application number: M012
Target Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION05e944d5-3473-4d8c-8df4-2ffc7474e9fa2025-11-05WarningsExact identifier
application number: M012
Target Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINTARGET CORPORATIONe36f179e-5aed-4fee-8b0a-767bf35907522025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d22025-11-05WarningsExact identifier
application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationf007beaa-b108-46d5-8a98-853f011a8e2e2025-11-05WarningsExact identifier
application number: M012
Target Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINTARGET CORPORATION975e157a-8f8d-41ad-b55b-9f9100188ccd2025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCLTARGET CORPORATION6e94fdab-27ea-4c0f-a91c-735ce697304b2025-11-05WarningsExact identifier
application number: M012
Target Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation76299495-7259-4bbe-8393-7eabfe22715a2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGHBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLTARGET CORPORATION05ac2a40-5eee-4013-b55b-6e370a28b21c2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENs COLD and COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATIONeb912834-1b14-484d-90f7-a8deb52c0d4e2025-11-05WarningsExact identifier
application number: M012
UP and UP Daytime Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationa2d99bc8-7295-4922-acff-0cb02c91273c2025-11-05WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILAMERISOURCE BERGENc1843f1a-ae5b-0fdf-e053-2995a90aae382025-11-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4754363d-e163-42e0-a65d-1c4bac24f6c92025-11-05WarningsExact identifier
application number: M012
Day Time Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLSafeway, Inc.76d62892-615d-4744-95aa-3be1207a0e572025-11-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN8ddf601b-c851-4604-b60c-f190fb8382318
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD8ddf601b-c851-4604-b60c-f190fb8382318
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY8ddf601b-c851-4604-b60c-f190fb8382318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-715-30553190715301 BOTTLE, SPRAY in 1 CARTON (55319-715-30) / 30 mL in 1 BOTTLE, SPRAY2020-02-280000-00-00NoNoCurrent