FDA.reportPublic FDA data

NO DRIP

Product NDC
55319-716
11-digit product format
553190716
Labeler code
55319
Product ID
55319-716_75d67030-8077-44b2-bff1-b42a8f552066
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
FAMILY DOLLAR SERVICES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-09
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
NO DRIP
Brand name suffix
NASAL MIST
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
55319-716-30NO DRIPNASAL MIST30 mL in 1 BOTTLE, SPRAYSPRAY308
55319-716-30NO DRIPNASAL MIST1 in 1 CARTONSPRAY18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-716NO DRIP NASAL MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [FAMILY DOLLAR SERVICES INC]7Current NDC, Legacy NDC, 2 package rows20240905_bf2030d9-f5c6-4e33-afc4-d2ccf23cd9c6.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 63 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
application number: M012
TusnelDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division805dc611-355a-4af5-bf19-464c3290c5c62025-12-31WarningsExact identifier
application number: M012
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONcc774d33-96ce-4992-ad30-3cb03b0d119d2025-12-31WarningsExact identifier
application number: M012
Tusnel SFDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cb43b4df-5ccc-416e-abcd-98f079b3f2bb2025-12-31WarningsExact identifier
application number: M012
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.63541753-de8d-42fe-a9b3-a5eac3fcdca42025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
application number: M012
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
application number: M012
Tusnel-DM PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION64e36b02-b5be-4d20-8818-cb5b235966712025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f89a64-f4a4-f909-e053-2a91aa0ad44d2025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f65f59-7ea1-adce-e053-2991aa0a6f1f2025-12-31WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLBestco Inc.77f9e176-d87a-beed-e053-2991aa0aac202025-12-31WarningsExact identifier
application number: M012
Sugar Free Cherry Cough DropsMENTHOLBestco Inc.7858f380-bef7-3d30-e053-2a91aa0a7ea62025-12-31WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLBestCo Inc.26a22cfd-395b-4ffb-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M012
Limpia PechoDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf32025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNbf2030d9-f5c6-4e33-afc4-d2ccf23cd9c68
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDbf2030d9-f5c6-4e33-afc4-d2ccf23cd9c68
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYbf2030d9-f5c6-4e33-afc4-d2ccf23cd9c68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-716-30553190716301 BOTTLE, SPRAY in 1 CARTON (55319-716-30) / 30 mL in 1 BOTTLE, SPRAY2020-03-090000-00-00NoNoCurrent